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Background
Obesity and type 2 diabetes are common in adults with a learning disability. It is not known if the principles of self-management can be applied in this population.
Objectives
To develop and evaluate a case-finding method and undertake an observational study of adults with a learning disability and type 2 diabetes, to develop a standard...
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Objective: Although interventions which provide psychosocial support can have a positive impact on diabetes self-care, the impact of family/peer- and theory-based interventions has not yet been clearly identified. This systematic review investigates the randomised controlled trials (RCTs) employing family/peer-based interventions (based on theoreti...
Citations
... There are challenges to identifying a representative group of people with learning disabilities who are also supported sufficiently to contribute to research. This study adopted an inclusive recruitment approach, deliberately avoiding IQ testing to prevent further exclusion; this follows a similar approach to previous research with this population [19]. Consequently, the participants with learning disabilities who assisted in the development of the adapted EQ-5D-3L may not have captured the entire spectrum of learning disabilities. ...
Background
Approximately 1.5 million adults in the UK have a learning disability. The difference between age at death for this group and the general population is 26 years for females and 22 years for males. The NHS Long Term Plan (January 2019) recognises learning disabilities as a clinical priority area. People with a learning disability are often excluded from research by design or lack of reasonable adjustments, and self-reported health status/health-related quality of life questionnaires such as the EQ-5D are often not appropriate for this population. Here, we systematically examine the EQ-5D-3L (its wording, content, and format) using qualitative methods to inform the adaption of the measure for use with adults with mild to moderate learning disabilities.
Methods
Think-aloud interviews with carers/advocates of learning-disabled adults were undertaken to explore the difficulties with completing the EQ-5D-3L. Alternative wording, language, structure, and images were developed using focus groups, stakeholder reference groups, and an expert panel. Data analysis followed a framework method.
Results
The dimensions and levels within the EQ-5D-3L were deemed appropriate for adults with mild to moderate learning disabilities. Consensus on wording, structure, and images was reached through an iterative process, and an adapted version of the EQ-5D-3L was finalised.
Conclusion
The EQ-5D-3L adapted for adults with mild to moderate intellectual/learning disabilities can facilitate measurement of self-reported health status. Research is underway to assess the potential use of the adaptation for economic evaluation.
... For nearly half this was because their diabetes was not type 2; the people caring for them had referred them because they didn't know the difference. 8 This highlighted a significant need for better understanding of diabetes in paid and family supporters. ...
... Only 22% used the internet, a third of whom needed help to do so. 8 Any purely webbased service can perpetuate inequalities in adults with a learning disability. ...
... When planning activity interventions, we found that high levels of fear and experiences of hate crime inhibited people's capacity to exercise in public close to home. 8 Safety and transport therefore require discussion in any conversation about physical activity so that unwarranted assumptions are not made. All activity-based interventions need a discussion of wider social and economic barriers. ...
... A pilot phase or study is indispensable to identify such factors and should therefore be included, especially if a large trial is planned. Therefore, more and more studies consider the additional effort of a pilot trial [7,8,11,37,38]. ...
Introduction
Several clinical studies investigated improvements of patient outcomes due to diabetes management interventions. However, chronic disease management is intricate with complex multifactorial behavior patterns. Such studies thus have to be well designed in order to allocate all observed effects to the defined intervention and to exclude effects of other confounders as well as possible.
This article aims to provide challenges in interpreting diabetes management intervention studies and suggests approaches for optimizing study implementation and for avoiding pitfalls based on current experiences.
Main body
Lessons from the STeP and ProValue studies demonstrated the difficulty in medical device studies that rely on behavioral changes in intervention group patients. To successfully engage patients, priority should be given to health care professionals being engaged, operational support in technical issues being available, and adherence being assessed in detail.
Another difficulty is to avoid contamination of the control group with the intervention; therefore, strict allocation concealment should be maintained. However, randomization and blinding are not always possible. A limited effect size due to improvements regarding clinical endpoints in the control group is often caused by the Hawthorne effect. Improvements in the control group can also be caused with increased attention paid to the subjects. In order to reduce improvements in the control group, it is essential to identify the specific reasons and adjust study procedures accordingly. A pilot phase is indispensable for this. Another option is to include a third study arm to control for enhanced standard of care and study effects. Furthermore, retrospective data collection could be a feasible option. Adaptive study designs might reduce the necessity of a separate pilot study and combine the exploratory and confirmatory stages of an investigation in one single study.
Conclusion
There are several aspects to consider in medical device studies when using interventions that rely on changes in behavior to achieve an effective implementation and significant study results. Improvements in the control group may reduce effect sizes and limit statistical significance; therefore, alternatives to the traditional randomized controlled trials may be considered.
... A casediscovering technique and an observational investigation of grown-ups with a learning handicap and type 2 diabetes were created and furthermore a practicality randomized controlled preliminary (RCT) of SSM versus treatment not surprisingly (TAU) was attempted. It is demonstrated that an authoritative RCT is practical and would need to select 194 members for every arm [22]. It was contemplated that how financial status, way of life factors and employment strain were identified with work incapacity in people with diabetes with and without comorbidity. ...
... Preventing or delaying the onset of T2DM is important because T2DM is a progressive disease that is associated with a range of microvascular and macrovascular complications, including peripheral neuropathy, chronic kidney disease, coronary artery disease, heart failure and stroke (Kosiborod et al. 2018). For people with ID who are already living with T2DM, diabetes management can be variable (Shireman et al. 2010;Taggart et al. 2013), but evidence suggests that, with the right support, they can be effectively involved in their own care (House et al. 2018). ...
... Whilst self-management education and support are core components of diabetes and glucose control (Davies et al. 2018), they must be seen in the context of ID. As well as inherent intellectual and adaptive behaviour impairments, people with ID and diabetes are disadvantaged in terms of additional comorbidities (House et al. 2018), choice of glucoselowering therapies (Axmon et al. 2017) and quality of care (Shireman et al. 2010;Taggart et al. 2013). It is vital that specially tailored management plans with multidisciplinary input from health care professionals are in place to meet their needs. ...
Background:
As people with intellectual disabilities (ID) are now living longer, they are more at risk of developing non-communicable diseases, including type 2 diabetes mellitus. However, understanding of factors associated with diabetes for targeted management and prevention strategies is limited. This study aimed to investigate prevalence of diabetes in adults (aged ≥18 years) with ID and its relationship with demographic, lifestyle, independence and health factors.
Method:
This was a cross-sectional analysis of interview data from 1091 adults with ID from the Leicestershire Learning Disability Register from 1 January 2010 to 31 December 2016. Logistic regression models were used to identify factors associated with diabetes in the study population.
Results:
The study population did not have healthy lifestyles: just under half reported having lower physical activity levels than people without ID of a similar age; one-quarter consumed fizzy drinks daily; and 20% consumed five or more fruit and/or vegetables per day. Prevalence of carer/self-reported diabetes was 7.3% (95% confidence interval 5.9-9.0). After adjustment, diabetes was positively associated with South Asian ethnicity (P = 0.03) and older age groups (P < 0.001). Diabetes was less common in people living with family members (P = 0.02). We did not find a relationship between any of the lifestyle, independence and health factors investigated.
Conclusions:
A significant proportion of people with ID are living with diabetes. Diabetes management and prevention strategies should be tailored to individuals' complex needs and include consideration of lifestyle choices. Such strategies may want to focus on adults of South Asian ethnicity and people living in residential homes where prevalence appears to be higher.
... Understanding the needs of people with learning disabilities can be difficult since these will vary greatly from people with mild disabilities who need occasional support to people with severe or profound learning disabilities who receive full time care (Flood & Henman, 2015;Mencap, 2015;Phillips, 2009;Rey-conde & Lennox, 2007). In relation to primary care services for people with diabetes and learning disabilities, House et al. (2018) point out that practice nurses may have limited experience of this population preventing them from developing the necessary expertise . Flood and Henman (2015) point out that some people with mild-to-moderate learning disabilities mask support needs with an appearance of self-sufficiency and a tendency to agree with professionals even if they have not understood what has been said. ...
... A case-study finding conducted in three districts of West Yorkshire with people with mild-tomoderate learning disabilities and type 2 diabetes controlled without insulin found that although glycaemic management was similar to that of the general population with type 2 diabetes, one fifth of their participants had higher than recommended HbA1c levels and the majority were overweight or obese (Bryant et al., 2017;House et al., 2018). ...
Questions have been raised over the quality of healthcare including primary care diabetes services for adults with learning disabilities. Despite numerous proposals and policies aimed at improving the quality of healthcare services for people with learning disabilities, little is known about what constitutes quality care from the perspective of key stakeholders. This thesis aimed to: i) explore the social construction of 'quality care' in terms of diabetes primary care appointments by adults with mild-to-moderate learning disabilities, those who support their diabetes management and healthcare professionals; ii) reveal any similarities and differences in the ways in which these different stakeholders constructed quality care; and iii) explore the social construction of responsibility for the provision of quality diabetes care appointments for this population. A discursive psychological analysis was conducted on twenty semi-structured interviews: eight adults with mild-to-moderate learning disabilities and diabetes, seven supporters and five healthcare professionals. The research demonstrated that different stakeholders drew on some common ideas to construct quality diabetes care appointments, notably that appointments should fulfil their purpose, stakeholders should fulfil their respective roles and responsibilities and that successful appointments are informed by medical and/or experiential knowledge. Stakeholders also drew on differential repertoires around the relationship between independence and quality diabetes care and practicalities and constraints in the provision of quality diabetes care. Different stakeholders were constructed as having different responsibilities. People with learning disabilities were often positioned as having a limited level of responsibility whilst others were positioned as accountable. Quality care was flexibly constructed to perform identity management for the speaker, to attribute responsibility and to justify care which deviated from recommended quality guidance for diabetes care. Likewise, responsibility for quality care was flexibly taken up and attributed. The findings of this thesis have implications for ongoing discussions about the nature of quality care for people with learning disabilities in diabetes services and beyond.
... The EQ-5D-3L was administered at baseline and 6 months as part of a wider research interview (see [26]). The project team including the Project Coordinator were trained in assessing mental capacity by a consultant psychiatrist. ...
... Throughout the research, it was noted that participants had difficulty with time, for example, recalling events in a sequence or recalling the amount of activity done in a week [26]. When administering the EQ-5D-3L, researchers frequently had to remind participants that they should respond in relation to 'how they feel right now' and some participants found it difficult to specify this he kept answering in quite general ways so when I was talking about pain and discomfort, he told me about how it was quite difficult for him to get up from the armchair and he uses a wheat bag to help with back pain and things like that but I kind of had to say well what about today, how are you feeling today (1284). ...
Background
In trials incorporating a health economic evaluation component, reliable validated measures for health-related quality of life (HRQOL) are essential. The EQ-5D is the preferred measure for cost-effectiveness analysis in UK trials. This paper presents a qualitative evaluation of the use of the EQ-5D-3L in a feasibility randomised control trial with participants who had a mild- to moderate learning disability and type 2 diabetes.
Methods
Researchers administered the EQ-5D-3L to 82 participants at baseline and 77 at follow-up. After each interview, researchers rated the ease of administering the EQ-5D-3L and made free-text entries on the administration experience. For a subset of 16 interviews, researchers audio-recorded more detailed journal entries. Ease of administration data were analysed using descriptive statistics. Free-text responses were subject to a basic content analysis. The EQ-5D-3L-related journal entries were transcribed, coded and analysed thematically.
Results
Over half of participants were perceived to experience difficulty answering some or all of the items in the EQ-5D-3L (60% at baseline; 54% at follow-up). Analysis of the free-text entries and audio journals identified four themes that question the use of the EQ-5D-3L in this population. The first theme is related to observations of participant intellectual ability and difficulties, for example, in understanding the wording of the measure. Theme 2 is related to the normalisation of adjustments for impairments, which rendered the measure less sensitive in this population. Theme 3 is related to researcher adaptation and non-standard administration. An overarching fourth theme was identified in that people with learning disabilities were viewed as ‘unreliable witnesses’ by both researchers and supporters.
Conclusions
It is recommended that the EQ-5D-3L should not be used in isolation to assess health-related quality of life outcomes in trials research in adults with a learning disability. Further research is required to develop and evaluate a version of the EQ-5D appropriate for this population in trials research. It is unrealistic to expect that adjustments to the wording alone will deliver an appropriate measure: supporter or researcher involvement will almost always be required. This requirement needs to be factored into the development and administration guidelines of any new version of the EQ-5D for adults with a learning disability.
Trial registration
Current Controlled Trials ISRCTN41897033 [registered 21 January 2013].
Electronic supplementary material
The online version of this article (10.1186/s40814-018-0357-6) contains supplementary material, which is available to authorized users.
... The OK diabetes program took a broadly problem-focused approach, seeking to identify specific barriers to good self-management and to help the individual marshal personal and social resources (especially instrumental social support) to overcome those barriers. Against this largely social and interpersonal background, individual change techniques such as goal setting could be modified to suit the participants' needs [39,40]. ...
... House et al. (2018) [40] undertook an individually randomized-feasibility controlled trial of the OK diabetes program vs usual care in England, randomizing 41 adults with mild-moderate IDD to the OK diabetes program and 41 adults to routine care [41]. Self-management sessions lasted on average 45 min and largely took place in the participant's home (92%). ...
... In the OK diabetes program, 35% of those who received supported selfmanagement either lost > 5% body weight or dropped HbA1c > 5.5 mmol/mol. House et al. (2018) [40] results suggest that the OK diabetes program is practical and acceptable, and recruitment and retention rates propose that a definitive trial is possible. Qualitative feedback suggested that important elements included face-to-face contact with the nurse, practical problem-solving involving supporters and goal setting. ...
Purpose of Review
The aim of this paper was to review the recent international developments in health promotion and wellness initiatives targeting chronic disease prevention and management for adults with intellectual and developmental disabilities (IDD) targeting type 2 diabetes (T2D).
Recent Findings
There has been one diabetes prevention program (STOP) and two self-management T2D education programs (DESMOND-ID; OK diabetes) adapted for this population. All three programs have been adapted from other theoretically informed and tested programs developed for the general population. Each program has employed co-design and co-production techniques with all stakeholders. The three programs all target the high-risk lifestyle factors that can lead to T2D and contribute to poor glycaemia control, and have undertaken randomized-feasibility studies, the results of which are promising.
Summary
This paper shows that any health promotion and wellness initiatives need to be tailored and reasonable adjustments made in order to address this population’s cognitive impairments and communication difficulties.
... We have recently completed a feasibility RCT of a supported self-management intervention for evaluation in a feasibility RCT, the OK Diabetes trial. The protocol for the OK Diabetes RCT [24] and the results for the trial [25,26] have been reported elsewhere. The present paper reports on our work in developing and field testing the intervention for use in the trial. ...
... The searches are available in the full report of the study [26]. ...
Background
Although supported self-management is a well-recognised part of chronic disease management, it has not been routinely used as part of healthcare for adults with a learning disability. We developed an intervention for adults with a mild or moderate learning disability and type 2 diabetes, building on the principles of supported self-management with reasonable adjustments made for the target population.
Methods
In five steps, we:Clarified the principles of supported self-management as reported in the published literature
Identified the barriers to effective self-management of type 2 diabetes in adults with a learning disability
Reviewed existing materials that aim to support self-management of diabetes for people with a learning disability
Synthesised the outputs from the first three phases and identified elements of supported self-management that were (a) most relevant to the needs of our target population and (b) most likely to be acceptable and useful to them
Implemented and field tested the intervention
Results
The final intervention had four standardised components: (1) establishing the participant’s daily routines and lifestyle, (2) identifying supporters and their roles, (3) using this information to inform setting realistic goals and providing materials to the patient and supporter to help them be achieved and (4) monitoring progress against goals.
Of 41 people randomised in a feasibility RCT, thirty five (85%) completed the intervention sessions, with over three quarters of all participants (78%) attending at least three sessions.
Twenty-three out of 40 (58%) participants were deemed to be very engaged with the sessions and 12/40 (30%) with the materials; 30 (73%) participants had another person present with them during at least one of their sessions; 15/41 (37%) were reported to have a very engaged main supporter, and 18/41 (44%) had a different person who was not their main supporter but who was engaged in the intervention implementation.
Conclusions
The intervention was feasible to deliver and, as judged by participation and engagement, acceptable to participants and those who supported them.
Trial registration
Current Controlled Trials ISRCTN41897033 (registered 21/01/2013)
Electronic supplementary material
The online version of this article (10.1186/s40814-018-0291-7) contains supplementary material, which is available to authorized users.
... This paper reports on the development and testing of data collection methods for an economic evaluation within a randomised controlled trial (RCT) for a supported diabetes self-management programme for people with a mild/moderate learning disability. A full description of the study is reported elsewhere [12], but in brief the study sought to explore the feasibility of conducting a definitive phase III randomised controlled trial to evaluate the clinical and cost-effectiveness of supported self-management of type 2 diabetes in adults with a mild or moderate learning disability and consisted of the following: (i) an initial case finding and recruitment study, (ii) development of materials to implement and evaluate an RCT of supported self-management, (iii) feasibility RCT of supported self-management + treatment as usual (SSM) vs. treatment as usual (TAU). As Fig. 1 shows, development and testing of data collection methods for an economic evaluation was undertaken in two phases, during the case finding study (phase I) and during the feasibility randomised controlled trial (RCT) (phase II). ...
... At baseline, 82 participants were interviewed, 40 males and 42 females and the mean age was 56.4 years; 77 of these participants were interviewed for a second time at follow-up. A full description of the complex recruitment process is reported elsewhere [12]. ...
Background
The challenges of conducting research with hard to reach vulnerable groups are particularly pertinent for people with learning disabilities. Data collection methods for previous cost and cost-effectiveness analyses of health and social care interventions targeting people with learning disabilities have relied on health care/health insurance records or data collection forms completed by the service provider rather than by people with learning disabilities themselves. This paper reports on the development and testing of data collection methods for an economic evaluation within a randomised controlled trial (RCT) for a supported self-management programme for people with mild/moderate learning disabilities and type 2 diabetes.
Methods
A case finding study was conducted to identify types of health and social care use and data collection methods employed in previous studies with this population. Based on this evidence, resource use questionnaires for completion by GP staff and interviewer-administered participant questionnaires (covering a wider cost perspective and health-related quality of life) were tested within a feasibility RCT. Interviewer-administered questionnaires included the EQ-5D-3L (the NICE recommended measure for use in economic evaluation). Participants were adults > 18 years with a mild or moderate learning disability and type 2 diabetes, with mental capacity to give consent to research participation.
Results
Data collection for questionnaires completed by GP staff requesting data for the last 12 months proved time intensive and difficult. Whilst 82.3% (121/147) of questionnaires were returned, up to 17% of service use items were recorded as unknown. Subsequently, a shorter recall period (4 months) led to a higher return rate but with a higher rate of missing data. Missing data for interviewer-administered participant questionnaires was > 8% but the interviewers reported difficulty with participant recall. Almost 60% (48/80) of participants had difficulty completing the EQ-5D-3L.
Conclusions
Further investigation as to how service use can be recorded is recommended. Concerns about the reliability of identifying service use data directly from participants with a learning disability due to challenges in completion, specifically around recall, remain. The degree of difficulty to complete EQ-5D-3L indicates concerns regarding the appropriateness of using this measure in its current form in research with this population.
Trial registration
Current Controlled Trials ISRCTN41897033 (registered 21 January 2013).
Electronic supplementary material
The online version of this article (10.1186/s40814-018-0266-8) contains supplementary material, which is available to authorized users.
