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Randomized controlled feasibility trial of supported self-management in adults with Type 2 diabetes mellitus and an intellectual disability: OK Diabetes.

ABSTRACT: AIMS:To undertake a feasibility randomized controlled trial of supported self-management vs treatment as usual in a population of adults with obesity, Type 2 diabetes and an intellectual disability. METHODS:We conducted an individually randomized feasibility trial. Participants were adults aged >18 years with a mild or moderate intellectual disability, living in the community with Type 2 diabetes, on any therapy other than insulin. Participants had mental capacity to consent to research and the intervention. Inclusion criteria included HbA1c > 48 mmol/mol (6.5%), BMI >25 kg/m2 , or self-reported physical activity below national guideline levels. The experimental intervention was standardized supported self-management delivered by diabetes specialist nurses plus treatment as usual, compared with treatment as usual alone. Feasibility outcomes included: recruitment and retention; intervention acceptability and feasibility; data collection and completeness for physiological state and values for candidate primary outcomes (HbA1c and BMI). RESULTS:A total of 82 participants (89% of those contacted and eligible) were randomized. All supported self-management sessions were completed by 35/41 participants (85%); only four completed no sessions. Data on the follow-up candidate primary outcomes HbA1c and BMI were obtained for 75/82 (91%) and 77/82 participants (94%), respectively. The mean baseline HbA1c was 56±16.5 mmol/mol (7.3±1.5%) and the mean BMI was 34±7.6 kg/m2 . CONCLUSIONS:Adherence to supported self-management and willingness to have blood taken for outcome measurement was good. A definitive randomized controlled trial is feasible in this population. (Trial registration: Current Controlled Trials ISRCTN41897033).

SUBMITTER: House A

PROVIDER: S-EPMC5969288 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Randomized controlled feasibility trial of supported self-management in adults with Type 2 diabetes mellitus and an intellectual disability: OK Diabetes.

House A A Bryant L L Russell A M AM Wright-Hughes A A Graham L L Walwyn R R Wright J M JM Hulme C C O'Dwyer J L JL Latchford G G Stansfield A A Ajjan R R Farrin A A

Diabetic medicine : a journal of the British Diabetic Association 20180419 6

<h4>Aims</h4>To undertake a feasibility randomized controlled trial of supported self-management vs treatment as usual in a population of adults with obesity, Type 2 diabetes and an intellectual disability.<h4>Methods</h4>We conducted an individually randomized feasibility trial. Participants were adults aged >18 years with a mild or moderate intellectual disability, living in the community with Type 2 diabetes, on any therapy other than insulin. Participants had mental capacity to consent to re ...[more]

PMID: 29575241

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Project description:BackgroundAlthough 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.MethodsIn five steps, we:Clarified the principles of supported self-management as reported in the published literatureIdentified the barriers to effective self-management of type 2 diabetes in adults with a learning disabilityReviewed existing materials that aim to support self-management of diabetes for people with a learning disabilitySynthesised 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 themImplemented and field tested the intervention.ResultsThe 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.ConclusionsThe intervention was feasible to deliver and, as judged by participation and engagement, acceptable to participants and those who supported them.Trial registrationCurrent Controlled Trials ISRCTN41897033 (registered 21/01/2013).

Project description:BackgroundDiabetes mellitus and hypertension are risk factors for cardiovascular disease, which is the most common cause of death in the world. People with intellectual disability (ID) have been reported to have high rates of both these disorders. The aim of this study was to describe and compare prevalence ratios of diabetes mellitus and hypertension between older adults with ID and their age peers in the general population, and to describe and compare treatment patterns in these two groups.MethodsThis is a Swedish register-based study, in which we established a cohort of people aged 55+ years and who had received support for those with ID in 2012 (n = 7936). We also established a same-sized referent cohort from the general population matched by sex and year of birth. Information on diagnoses of diabetes mellitus and hypertension, and prescription of drugs for these disorders, were collected from national registers for the period 2006-2012. The two cohorts were compared using generalized linear models (GLM).ResultsPeople with ID were 20% more likely than the general population to have a diagnosis of diabetes mellitus, and 26% more likely to have prescription of drugs for diabetes mellitus. People in the general population were 81% more likely to have a diagnosis of hypertension, and 9% more likely to have a prescription of drugs for hypertension. Among those with diabetes, ID was associated with higher occurrence of prescription of insulin combination drugs and sulfonylureas, but lower occurrence of prescription of dipeptidyl peptidase (DPP) 4-inhibitors and exenatide/liraglutide. Among those with hypertension, ID was associated with higher occurrence of prescription of diuretics, but lower occurrence of prescription of calcium channel blockers and angiotensin II antagonists.ConclusionsTreatment regimens among people with ID tended to include older types of medication compared with what was prescribed in the general population. To ensure that this is medically appropriate and not due to failure to update the treatment regimen, it is important to investigate if the people with ID and diabetes mellitus or hypertension are subjected to the same regular drug reviews that are recommended for older adults in general.

Project description:Background/objective(s)Psychotropic medications are commonly prescribed among adults with intellectual disability, often in the absence of a psychiatric diagnosis. The aim of this scoping review is to provide an overview of the extent, range, and nature of the available research on medication use and practices and medication management in people with intellectual disability taking psychotropic medications for behaviours that challenge.Materials and methodsA scoping review of research studies (qualitative, quantitative, and mixed design) and Grey Literature (English) was carried out. Databases included: Ovid MEDLINE, Embase, CINAHL, JBI Evidence Synthesis, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, and Scopus. A three-step search strategy was followed, with results screened by two independent reviewers. Data was extracted independently by two reviewers using a data extraction tool with results mapped and presented using a narrative form supported by tables and diagrams to the research questions.ResultsFollowing the removal of duplicates, records were screened, full texts assessed, and 49 studies were included. Medication outcomes included reduced repetitive, stereotypic, and/or aggressive behaviours. High dosing/prescribing in the setting of an absent/unclear clinical indication was associated with worsening of symptoms for which psychotropics were prescribed. While psychotropics had a role in managing behaviours that challenge, reducing or discontinuing psychotropics is sometimes warranted. Study designs were frequently pragmatic resulting in small sample sizes and heterogeneous cohorts receiving different doses and combinations of medications. Access to multidisciplinary teams, guidelines, medication reviews, staff training, and enhanced roles for carers in decision-making were warranted to optimize psychotropic use.ConclusionsThese findings can inform prescribing interventions and highlight the need for timely and comprehensive patient outcome data, especially on long-term use of high doses of psychotropics and what happens when reduce or stop prescribing these doses.KEY MESSAGESPsychotropic medications are frequently prescribed for people with intellectual disabilities, often at high doses and these medications are associated with both positive and negative patient outcomes.Work to rationalize psychotropic use has been reported with interventions aiming to reduce polypharmacy or deprescribe a single psychotropic medicine. These interventions had mixed success and risk of relapse was documented in some studies.Limitations in sample size and heterogenous patient cohorts make it challenging to understand the risks and benefits associated with reducing or stopping psychotropic medicines.Patient, carer, and clinician partnerships are critical to advance medication management.

Project description:OBJECTIVES:To compare the effect of a 6-month community-based intervention with that of usual care on quality of life, depressive symptoms, anxiety, self-efficacy, self-management, and healthcare costs in older adults with type 2 diabetes mellitus (T2DM) and 2 or more comorbidities. DESIGN:Multisite, single-blind, parallel, pragmatic, randomized controlled trial. SETTING:Four communities in Ontario, Canada. PARTICIPANTS:Community-dwelling older adults (≥65) with T2DM and 2 or more comorbidities randomized into intervention (n = 80) and control (n = 79) groups (N = 159). INTERVENTION:Client-driven, customized self-management program with up to 3 in-home visits from a registered nurse or registered dietitian, a monthly group wellness program, monthly provider team case conferences, and care coordination and system navigation. MEASUREMENTS:Quality-of-life measures included the Physical Component Summary (PCS, primary outcome) and Mental Component Summary (MCS, secondary outcome) scores of the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12). Other secondary outcome measures were the Generalized Anxiety Disorder Scale, Center for Epidemiologic Studies Depression Scale (CES-D-10), Summary of Diabetes Self-Care Activities (SDSCA), Self-Efficacy for Managing Chronic Disease, and healthcare costs. RESULTS:Morbidity burden was high (average of eight comorbidities). Intention-to-treat analyses using analysis of covariance showed a group difference favoring the intervention for the MCS (mean difference = 2.68, 95% confidence interval (CI) = 0.28-5.09, P = .03), SDSCA (mean difference = 3.79, 95% CI = 1.02-6.56, P = .01), and CES-D-10 (mean difference = -1.45, 95% CI = -0.13 to -2.76, P = .03). No group differences were seen in PCS score, anxiety, self-efficacy, or total healthcare costs. CONCLUSION:Participation in a 6-month community-based intervention improved quality of life and self-management and reduced depressive symptoms in older adults with T2DM and comorbidity without increasing total healthcare costs.

Project description:Supported self-management reduces asthma-related morbidity and mortality. This paper is on a feasibility study, and observing the change in clinical and cost outcomes of pictorial action plan use is part of assessing feasibility as it will help us decide on outcome measures for a fully powered RCT. We conducted a pre-post feasibility study among adults with physician-diagnosed asthma on inhaled corticosteroids at a public primary-care clinic in Malaysia. We adapted an existing pictorial asthma action plan. The primary outcome was asthma control, assessed at 1, 3 and 6 months. Secondary outcomes included reliever use, controller medication adherence, asthma exacerbations, emergency visits, hospitalisations, days lost from work/daily activities and action plan use. We estimated potential cost savings on asthma-related care following plan use. About 84% (n = 59/70) completed the 6-months follow-up. The proportion achieving good asthma control increased from 18 (30.4%) at baseline to 38 (64.4%) at 6-month follow-up. The proportion of at least one acute exacerbation (3 months: % difference -19.7; 95% CI -34.7 to -3.1; 6 months: % difference -20.3; 95% CI -5.8 to -3.2), one or more emergency visit (1 month: % difference -28.6; 95% CI -41.2 to -15.5; 3 months: % difference -18.0; 95% CI -32.2 to -3.0; 6 months: % difference -20.3; 95% CI -34.9 to -4.6), and one or more asthma admission (1 month: % difference -14.3; 95% CI -25.2 to -5.3; 6 months: % difference -11.9; 95% CI -23.2 to -1.8) improved over time. Estimated savings for the 59 patients at 6-months follow-up and for each patient over the 6 months were RM 15,866.22 (USD3755.36) and RM268.92 (USD63.65), respectively. Supported self-management with a pictorial asthma action plan was associated with an improvement in asthma control and potential cost savings in Malaysian primary-care patients.Trial registration number: ISRCTN87128530; prospectively registered: September 5, 2019, http://www.isrctn.com/ISRCTN87128530 .

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Randomized controlled feasibility trial of supported self-management in adults with Type 2 diabetes mellitus and an intellectual disability: OK Diabetes.

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Randomized controlled feasibility trial of supported self-management in adults with Type 2 diabetes mellitus and an intellectual disability: OK Diabetes.

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