Abstract
Introduction
Trends in the redesign of health care are focused upon both a greater emphasis on chronic condition management rather than acute episode intervention and a recognition that prevention, self-management, and patient activation are critical (Ferretti, McCallion, Paeglow, & Kintner, 2011).
The Chronic Disease Self-Management Program (CDSMP) is among the most widely researched health promotion/self-management interventions for adults with chronic health conditions. People with developmental disabilities rarely participate in CDSMP despite strong interest from multiple Federal agencies in seeing these individuals included. Extending CDSMP to people with developmental disabilities is important given data that as people with developmental disabilities age have 2.5 times the health problems and a greater variety of health care concerns compared to those of the same age and gender in the general population. Central nervous system compromise associated with specific disabilities (e.g., epilepsy and cerebral palsy), it may present additional health risks, and there is increased seizure activity, mobility impairments, mental health problems, and sensory impairments (for a review see McCallion, Jokinen, & Janicki, 2017).
The concern is all the more pressing when we consider that although life expectancy for persons with developmental disabilities has been reported to have increased from an average 18.5 years in the 1930s to an estimated 66.2 years in 1993 (Braddock, 1999) and that by 2020 the number of those over 65 is projected to have doubled (Janicki & Dalton, 2000), data from several countries suggest longevity increases have stalled (Lauer & McCallion, 2015; McCarron et al., 2015). Targeting in middle-age behaviors and activities associated with increased chronic conditions and thereby increasing opportunities for healthy and positive aging seems critical. There are reports that adults with developmental disabilities as compared to the general population are more likely to lead sedentary lifestyles (McGuire, Daly, & Smyth, 2007), have nutritionally poor diets (Ewing, McDermott, Thomas-Koger, Whitner, & Pierce, 2004; Humphries, Traci, & Seekins, 2008), participate less in physical activity (Temple & Walkley, 2003), and are less likely to have benefited from preventive health screening and health promotion (Bigby, McCallion, & McCarron, 2014; McCarron et al., 2011). Increased potential for diabetes, hypertension, heart disease, and arthritis late in life (Bigby et al., 2014; Evenhuis et al., 2001; McCallion, Swinburne, Burke, McGlinchey, & McCarron, 2013; McCallion et al., 2017) may be ameliorated if interventions target these modifiable factors.
In terms of responding to such needs, relying upon programs that in effect segregate individuals with disabilities may violate the Americans with Disabilities Act integration mandate [28 C.F.R. § 35.130(b)(1)]. Instead, there is an obligation to explore options that will support participation in genuine community-based options. Also, offering classes that include people with developmental disabilities may make successful delivery of evidence-based health promotion classes themselves more viable. The addition of these individuals to the classes will increase enrollment in turn helping increase intervention minimum attendee requirement adherence.
The CDSMP is a manualized workshop for people with different chronic conditions with goals to develop the skills needed for the day-to-day management of their conditions and to maintain and/or increase life’s activities. The intervention is offered as a small-group, highly interactive workshop over 6 weeks, meeting once a week for 2 ½ hours, using an approved curriculum, and facilitated by a pair of trained leaders.
A randomized control trial compared health behaviors, health status, and health services use in patients age 40 to 90 years (average age 65) who had completed the CDSMP (Lorig & Holman, 2003). The 6-month posttest findings for participants (as compared to controls) were that the CDSMP increased rates of physical activity, coping, symptom management, and communication with their physicians and improved self-rated health, disability, social and role activities, and health distress with reports of more energy and less fatigue, and decreased disability as well as fewer physician visits and hospitalizations. At 1 year, CDSMP participants continued to have significant improvements in energy, health status, social and role activities, and self-efficacy; and less fatigue or health distress; fewer visits to the emergency room; and no decline in activity or role functions, despite there being a slight increase in disability after 1 year. Many of these improvements were found to be sustained in subsequent follow-up measurement (see Brady et al., 2013; Lorig & Holman, 2003).
People with developmental disabilities who are aging are, therefore, likely to benefit from participation in community based CDSMP delivery. However, in interviews conducted by the researchers with a national group of master trainers and CDSMP leaders a challenge was identified that use of the existing manual alone is not sufficient to genuinely and successfully include people with development disabilities in the classes. Specific barriers identified included: (a) literacy issues with materials, (b) lack of a tested translation for this population, and (c) the need to offer specific training and tools to community-based intervention leaders to ensure people with developmental disabilities are full participants in the intervention. A need for additional supportive materials and aides was identified. To be established is whether such additional materials will increase successful inclusion while maintaining fidelity to the core elements of the intervention.
A study objective was established to examine the feasibility of using supplementary materials to the existing CDSMP intervention manual as a facilitator to (a) overcoming barriers to the successful inclusion of people with developmental disabilities and (b) ensuring the continued successful implementation of the intervention. More specifically, it was hypothesized that (a) people with developmental disabilities and CDSMP leaders would report that the materials were useful and facilitated inclusion and (b) use of such supplemental materials would (1) result in completer levels for people with developmental disabilities similar to those reported for the general population (approximately 70%) as well as (2) achieve levels of reported self-management of chronic disease symptoms and reductions in health service utilization such as emergency room visits, hospitalizations and doctor visits, also similar to those reported for the general population (Brady et al., 2013; Lorig & Holman, 2003)
Method
This project is a feasibility study using mixed methods and advances the integration of an evidence-based intervention into practice settings—in this case by promoting the inclusion of people with developmental disabilities.
There is ambiguity regarding definitions of feasibility versus pilot studies (Eldridge et al., 2016; Thabane et al., 2010). The work here is at a more preliminary yet important stage than traditional pilot studies. The study design reflects that there is a need to develop and test the materials to examine the potential to measure outcomes before a more formal assessment of intervention outcomes and to preliminarily evaluate participant and leader responses to the intervention using the developed materials to identify if the materials show promise of being successful with the intended population materials (Orsmond & Cohn, 2015).
Intervention
Supplementary materials for people with developmental disabilities were developed under the supervision of a CDSMP National T-trainer (LAF—someone certified by the developer to train both trainers and leaders in the CDSMP intervention) and the development process was informed by data from focus groups of people with developmental disabilities, care staff, provider nurses, administrators, and family members. The other investigator, an expert in programming for people with developmental disabilities, utilized similar input from participating stakeholders to inform efforts to create materials that made both the content and presentation of ideas and activities more accessible. Emphases were on maintaining fidelity to the core requirements of the original randomized control trialed intervention and on utilization and successful completion of all CDSMP required activities and materials. Supplementary materials were developed at a first and second grade reading level and utilized graphics and checklists to support understanding and adherence to the program’s requirements. Development of materials assumed that some participants would be able to use the materials themselves and others would be supported by an accompanying caregiver.
The supplementary materials to be used with the existing intervention manual were designed to offer (a) graphics and simplified text to reinforce CDSMP tools, charts, key messages, and activities and (b) notebook pages where participants were able to record what they learned in the session and their own to do list for between session activities to prepare for classes and to note the specifics of each week’s action plan. The materials were printed in color and presented in a three-ring binder with the opportunity to add one’s name and to personalize the cover. All participants also received a copy of the “Living a Healthy Life with Chronic Conditions” book which is standard in the delivery of the CDSMP.
Participants
The target population was people with mild and moderate developmental disabilities living in community settings such as family homes, independent and supervised apartments, and small-group settings who were seeking to access most of their health services from community (rather than developmental disability specific) locations and who also had at least one chronic health conditions. The test populations were recruited from two large services providers. Staff at these organizations, who themselves had at least one chronic condition and were not assigned to support the individuals with developmental disabilities who were attending, also had the opportunity to sign up for the workshop. All participants consented to participate and to have data collected on their participation.
Approach
To test the feasibility of developed supplementary materials the materials were utilized within two CDSMP workshops each involving seven to nine persons with developmental disabilities and five to seven staff who also participated in the workshop activities. The workshops were held at a day program site, one in the morning and one immediately after lunch. The times were chosen to minimize transportation challenges and disruption of other activities.
The program consisted of workshops given in 2 ½ hours, once a week, for 6 weeks. People with different chronic conditions attended the same workshop together. The workshop leaders followed the scripted Workshop Leader’s Manual. The course developers have scripted the course for content as well as the interactions of the workshop leaders with workshop participants. Content included (a) developing decision-making and problem-solving skills; (b) developing and maintaining a safe and long-term physical activity program; (c) fatigue management; (d) dealing with anger, depression, and other difficult emotions; (e) cognitive management of pain and stress; (f) communicating effectively with family, friends, and health professionals; (g) using prescribed medication appropriately; (h) healthy eating; (i) making informed treatment decisions; and (j) planning for future health care.
For the purposes of the feasibility study, the workshops were co-led by two experienced CDSMP leaders (both previously trained at the master trainer level) and included one of the researchers. The other researcher (LAF) unobtrusively observed classes for fidelity and interviewed the leaders after each class to better understand their experience of delivery successes and challenges. Process interviews were completed with the leaders and participants at the end of sessions to (a) understand how well the materials worked and (b) identify the need for changes. Interviews with the leaders and the t-trainer also assessed where challenges emerged for fidelity and how these could be best handled. Finally, using the content section of the Stirman et al. (2013) framework and coding system for modifications and adaptions of evidence-based interventions, modifications to the CDSMP delivery were categorized and assessed.
Measures
Measures included demographic data on participants including age, gender, level of developmental disability, and health conditions of participants (persons with and without developmental disabilities); t-trainer observation notes on sessions and interviews with participants and leaders; and pre- and postquestionnaires using previously developed measures for CDSMP programs on health status, health services utilization, and perceived self-efficacy to manage different aspects of one’s health and functioning (Brady et al., 2013; Lorig et al., 1999, 2001). Consistent with the methodology, the assessment of the instruments was about testing feasibility of administration and sensitivity to change rather than formal outcome measurement.
The health measures tested included (a) the self-rated health scale used in the National Health Interview Survey and a modified version of the Health Assessment Questionnaire (HAQ) physical disability scale, (b) the energy/fatigue scale was from the long-form Medical Outcomes Study (MOS) measures, (c) the health distress scale slightly modified from the MOS health distress scale assesses the amount of time one feels distressed about health (e.g., discouraged, worried, fearful, frustrated by health problems), and (d) a social/role activity limitation scale previously developed and tested to determine role function.
Four types of health care utilization were also assessed for pre- and postintervention. These included visits to physicians, visits to the emergency room (ER), number of hospitalizations, and number of nights spent in a hospital over the previous 2 months.
A self-efficacy measure of perceived adaptability to manage different aspects of chronic disease, such as pain and fatigue (Cronbach’s alpha = 0.89), was used that combines two scales developed and validated for the CDSMP.
Participants also completed a participant satisfaction survey at the end of the class addressing satisfaction with location, leaders, support received, and usefulness of the materials.
To the extent possible, all participants answered questions for themselves although they could designate a proxy to assist. Prior work suggested that most participants with mild and moderate developmental disabilities would be able and interested in answering for themselves (McCallion et al., 2013).
Analysis
Summary notes were developed for the sessions and interviews, and these were reviewed by the researcher and the t-trainer to determine (a) if the materials proved useful and feasible, (b) how well fidelity was maintained, and (c) where changes to the written materials should be considered. The two members of the analysis team reviewed the notes and transcripts of the interviews independently and then met to reconcile and resolve any differences in conclusions about usefulness, feasibility, fidelity, and need for changes.
Completion rates of pre- and posttest questions by participants with developmental disabilities in all measurement areas were assessed, rates of self-completion determined, and both sensitivity to change over time and trends for improved level of self-management activity among the participants with developmental disabilities were examined. Levels of satisfaction with the intervention were established and implications for location, leaders, and materials were considered. Personal characteristics (such as level and types of disability, types of health conditions, and verbal and literacy levels) associated with level of success in the workshops were also considered. Pre to post differences were assessed using t tests with .05 as the guiding significance levels. Means and standard deviations and percentage were used to categorize other data as suitable.
Ethics
The study was one element in an overall evaluation of implementation of evidence-based health promotion programs reviewed and approved by the Institutional Review Board at the University at Albany.
Results
Participants with developmental disabilities were equally male and female, with an average age of 43 years (range from 35 to 54 years). In contrast, staff participants were mostly female with an average age of 48 years (range from 45 to 56 years). Participants with developmental disabilities had an average of four chronic conditions and other participants had a similar average.
Overcoming Barriers to the Successful Inclusion of People With Developmental Disabilities and Ensuring the Continued Successful Implementation of the Intervention
The two sets of classes were successfully delivered with completer rates for those who attended two or more sessions of over 70% (attended four or more sessions). There were three dropouts by Session 2. Two individuals had transportation problems that could not be resolved to ensure their arrival for the class, and one individual who obtained a part-time job had to work on the day of the class.
Participation in CDSMP activities
All CDSMP activities were successfully delivered with both groups. Action planning and reporting on action plans appeared to be particularly enjoyed by participants with developmental disabilities. Participants expressed mutual support, which was apparent during activities and while questions and comments were shared. Problem-solving steps took some time to be grasped by a number of participants with developmental disabilities, but consistent repetition of the steps and pointing to the guiding chart helped many to grasp the approach as the intervention proceeded. Brainstorming proved more challenging with participants with developmental disabilities offering few examples, but they remained interested in the topics and listened to the ideas of others. There was a noticeable difference in the energy of participants with developmental disabilities in the afternoon as compared to the morning class, yet there was still good participation. Although staff participants were at times providing additional assistance to participants with developmental disabilities (e.g., pointing out pages and repeating statements), by the second session there was a noticeable change in relationships. Action planning reports became an equalizer (i.e., “we all struggle”), where both groups of participants offered each other encouragement.
Ratings of modifications to intervention
Utilizing the Stirman et al. (2013) framework, a review by the collaborating t-trainer found that modifications to the intervention were only in content areas and at a population level (targeting people with developmental disabilities). Workshop leaders noted that at times they experienced a need to simplify conceptual explanations as compared to their presentation of material in workshops where no persons with developmental disabilities were in attendance. However, they also reported that the staff participants were successfully included meaning there were no barriers to participation experienced by those staff or changes to opportunities to complete all required activities. Similarly, reviews of the modifications to the content (see Table 1) found that these were more in the areas of tailoring/tweaking/refining with the supplemental materials as an added element. For example in “action planning” activities individuals with developmental disabilities had the opportunity to write their plan on a provided template and this offered additional structure so that all elements of an action plan (What?—How Much?—When?—How Often?) were included and available to be consulted during the week until the next session. The only other difference noticed in this delivery approach as compared to other deliveries of the CDSMP was that some concepts were presented more quickly, usually because there were fewer questions. However, no material was left out and all content was delivered consistent with the established manual.
Types of Content Modification.
Source. Adapted from Stirman et al. (2013).
Use of materials
All participants with developmental disabilities were pleased to receive the supplemental materials, added names and personalization to the three-ring binder they were given, and turned to relevant pages when prompted by the leaders. Consistent with the CDSMP approach, use of the materials in the session was limited to familiarization and to activities such as action planning. Participants with developmental disabilities were supported to ensure full inclusion in each session and process. This included group discussions, problem solving, brainstorming, and other interactive activities. Support materials enhanced participants’ use of wall charts and other materials used in delivery. Participants were encouraged to take the supplemental materials home, and frequently across the six workshop sessions, participants reported at-home review of materials at times with assistance from peer and staff and/or family members. The same at home supports providing requested assistance in reading and review of sections of the Living a Healthy Life with Chronic Conditions book. All participants with developmental disabilities maintained their supplemental binder materials and brought them to class each week.
Materials for each session were added at the beginning of the session, and many participants with developmental disabilities quickly wanted and expected to receive the materials for the class they were about to attend. Some participants were able to read sections of the materials themselves while others relied on the graphics and symbols. In most cases, reports indicated that materials were jointly read with support and had the effect of encouraging conversations between classes about prior class content as well as a prompt about that week’s action plan.
The template within the supplemental materials for answering the questions that guide completion of the components of an action plan quickly became a valued supplement to the activity. Staff participants were observed at times also utilizing the template to complete and report their own action plans and commented on its usefulness.
Maintenance of fidelity
T-trainer observations concurred that the two leaders delivered each activity under each session as specified in the approved CDSMP Leader Manual. There were occasions where some participants with developmental disabilities chose not to participate in some of the activities. Given that CDSMP is a self-management model program, it is expected that participants decide when and how they wish to participate in activities; however, it is possible that some participants did not fully understand a particular activity. This sporadic lack of participation, however, did not impact attendance at sessions. There were also a small number of instances where individuals with developmental disabilities wanted to talk about topics not part of the session, but they were easily redirected back to the session content which represents a standard class management strategy for the model. Some of the content in Session 4 (dealing with anger, depression, and other difficult emotions) and Session 5 (cognitive management of pain and stress) was difficult to convey. Similarly, some of the self-management techniques were not fully understood by some of the participants with developmental disabilities. To the extent possible, explanations were repeated, less complex (but consistent) language was added, and relevant pages in the supplemental materials were pointed out. This was helpful to some but not for others; however, all participants with developmental disabilities were still able to participate. At times, some participant statements to class members seemed judgmental of the participation and success of others but, again, the leaders successfully redirected such comments and encouraged problem solving. And again, this represents standard class management strategies in the model. Some similar issues occurred for other participants but not as frequently.
Outcome measures
All attempted measures were completed although there was enough difficulty with completing the energy/vitality questions among participants with developmental disabilities that they were not analyzed. As may be seen in Table 2, there was evidence of change over time in the two administrations and changes were in the desired direction except for pain in the last week for participants with developmental disabilities. All participants were able to answer questions seeking subjective appraisals (e.g., of their health). Objective questions such as number of physician visits in the prior 2 months were answered by approximately 50% of participants with developmental disabilities. In all cases, health care utilization answers were confirmed by a proxy often after consulting records. And in almost all cases, self-reports were correct. In one case, a reported visit to a physician was verified as a visit to a nutritionist. There was little variation noted in use of physician visits and few hospital days in the 2 months prior and the 2 months post the intervention for both groups. There were fewer uses of emergency rooms in both groups pre to post. There was also little variation pre to post in HAQ (DI) and in health distress and role activity limitation scores.
Outcome Measures.
Participant satisfaction
All participants with and without developmental disabilities rated the class and the leaders very highly. Satisfaction survey statements like “loved it,” “feel better,” and “can’t we meet next week” were common. The sessions were held at a day program site. Sometimes there were interruptions with staff and other consumers with developmental disabilities “stopping in.” This was more of a concern to the leaders than it appeared to be to the participants but, after consultations with center supervisory staff, the leaders indicated that the frequency of such interruptions declined significantly and was manageable by the second session for both groups.
Discussion
The study had the objective of purposefully examining for the first time the feasibility of using supplementary materials as facilitators to (a) overcoming barriers to the successful inclusion of people with developmental disabilities (in CDSMP classes) and (b) ensuring the continued successful implementation of the intervention. More specific hypotheses were that (a) people with developmental disabilities and CDSMP leaders would report that the materials were useful and facilitated inclusion and (b) use of such supplemental materials would (1) result in completer levels for people with developmental disabilities similar to those reported for the general population (approximately 70%) as well as (2) achieve levels of reported self-management of chronic disease symptoms and reductions in health service utilization such as emergency room visits, hospitalizations and doctor visits, also similar to those reported for the general population.
Qualitative analysis of notes and interviews established feasibility and demonstrated that it was possible both to successfully include people with developmental disabilities in classes and that the materials developed would make it be possible to sustain such inclusion. Few concerns with the supplemental materials were identified during the delivery process by leaders or raised during the qualitative review. Of note was the expressed sense both of individual ownership of the supplementary material binders and the supportive use of materials in class. In addition, the supplemental materials were noted in interviews as supporting between class engagement with others at home.
All sessions were found to be successfully delivered although some activities were more challenging for people with developmental disabilities, particularly (a) in the session on dealing with anger, depression, and other difficult emotions and (b) in the session on cognitive management of pain and stress. It was found that there were concepts that some participants with developmental disabilities had difficulty understanding, but there was continued attention and other meaningful participation in those sessions. Review of notes, interviews, and observations also found that fidelity was maintained throughout, no activity was omitted, and there was a high level of action planning.
The traditional outcome measures used for CDSMP were successfully implemented although with some use of proxy responses for individuals with developmental disabilities. Consistent with the hypotheses, the trends across items were for increases over time in physical activity and for improvements in symptom management except for “pain in past week” for participants with developmental disabilities. Trends for improvement were therefore similar to what has been previously reported for participants without identified developmental disabilities. This bodes well for more formal testing of the use of CDSMP with people with developmental disabilities. Other hypotheses were less well supported. There was little movement found in health distress and role activity limitation scores and in health care utilization scores over the short 2-month follow-up period utilized in the feasibility study. Additional studies with larger samples and to the use of a 6-month reporting period found in the larger CDSMP literature (Brady et al., 2013) are recommended for future studies.
Of particular note was the successful blending of participants with and without developmental disabilities. Participants without an identified developmental disability were staff, and one would expect they would be more ready to accept people with developmental disabilities. However, staff participants acknowledged in interviews that the sense of “caregiver” and “cared for” quickly disappeared in the class. Everyone in the class had chronic conditions they wished to manage better.
Findings are limited by (a) this being a feasibility study rather than a controlled evaluation, (b) the small sample size restricting statistical analysis, (c) the short follow-up period—2 months rather than 6, (d) the participants not being representative of all persons with developmental disabilities and (e) participants, including those without a developmental disability, being linked to service providers. Future research on deliveries that include people with chronic conditions who are not associated with providers of services to people with developmental disabilities will further test the success of inclusive groups. In both groups, the persons with developmental disabilities and the staff participants were younger than ages reported by many community workshops. With an average of four chronic health conditions, the participants with developmental disabilities presented with similar levels of chronic disease concerns as other CDSMP participants. Compressed longevity further encourages the inclusion of people with developmental disabilities in their 40s and 50s to increase opportunities for healthy aging.
The high levels of attendance speak to viability for these classes. However, there were challenges to be managed around transportation and the scheduling of other activities to limit disruptions in attendance. These issues may arise for everyone, but people with developmental disabilities are likely to have less control of their own transportation and schedules.
Conclusion
As noted earlier, people with developmental disabilities tend to have more comorbid conditions than the general population. Making self-management more accessible to people with developmental disabilities as they approach their aging years in mainstream rather than segregated settings has the potential to improve the quality of people’s lives. The findings here demonstrate that a new or different intervention is not needed: CDSMP delivered with fidelity and with some supplemental materials represents an effective integrated approach.
Footnotes
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
Ethics
The study was one element in an overall evaluation of implementation of evidence-based health promotion programs reviewed and approved by the Institutional Review Board at the University at Albany.
