Diabetes, learning disabilities Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Phase 1:
1. A simple checklist will be developed to enable staff working in primary care (and in a range of other NHS and non-NHS settings) to identify potential participants as they undertake Quality
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase 1: 1. Aged 18 years or over 2. Suffering from Type 2 diabetes which is diet-controlled or treated with hypoglycemic agents other than insulin 3. With a mild to moderate Learning Disability, defined by functional deficits (in daily activities, educational and social attainment and support needs, day-to-day cognitive functions of memory and knowledge) attributable to primary or secondary (acquired) cognitive impairment determined by consensus review 4. Living in the community (not in a hospital setting) Phase 2: Participants found to be eligible in phase I, meeting the following criteria, are eligible for entry, providing they do not meet any of the exclusion criteria: 1. Providing written informed consent (assessment of mental capacity to consent will be repeated by the Study Researcher) 2. Having inadequate diabetes control defined as HbA1c >7.5% taken from the latest QOF review where this is available in the last 3 months prior to randomisation or from a baseline blood test, taken just prior to randomisation, if not
Exclusion criteria
Exclusion criteria: Phase 1: 1. Insufficient mental capacity to consent or to participate in the research, as assessed by the Study Researcher following guidelines using the Mental Capacity Act (2005) with people with learning disabilities (http://www.scie.org.uk/publications/mca/files/bild-mca.pdf). Study Researchers will be trained by LD consultant to undertake this assessment. 2. Problems acquired from disease in adult life, defined as 16 years or over, such as learning difficulty due to adult-onset dementia or stroke 3. Secondary diabetes (such as steroids, pancreatitis, endocrine disorders etc.) and rare causes of diabetes (such as MODY: maturity onset diabetes of the young) Phase 2: 1. Referred for insulin or put on insulin between identification (Phase I) and randomisation 2. Participated in development of the self-help materials, adherence measure or health economics analyses in Phase I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: 1. Estimate the number of people who meet the inclusion criteria, and the numbers willing to consider change and to participate in further research 2. Characterize the population in terms of important characteristics such as diabetes control, living circumstances and presence and involvement of a supporter in diabetes management 3. Develop self-management materials and adherence measure and field-test them for acceptability in a case series of six people Phase 2: In the definitive trial HbA1c would be used at 12 months as the primary outcome, to estimate treatment differences between arms. A 12 month follow up interval will allow comparison with other published diabetes trials. It will also be compatible with an intervention the main effect of which is measured through routine NHS service delivery in the QOF system. For the feasibility RCT there will be 6 months follow up, which will be adequate for the main outcomes: 1. Variability of: 1.1. HbA1c 1.2. Blood pressure (BP) 1.3. Body mass index (BMI) 2. Recruitment rates 3. 6 months follow up rates | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2 secondary outcomes are: 1. Patient and supporter costs 2. Participant and supporter reported adherence to diet and activity (Summary of Diabetes Self-Care Activities) 3. Participant and Carer Mood (PHQ9) 4. Health Related Quality of Life (HRQL) (SF12 and EQ5D) 5. Medication use Feasibility and data quality outcomes are: 1. Feasibility of collecting 6 month outcome measures based on blood tests from routine data from QOF reviews 2. Feasibility of collecting data on adherence to the intervention 3. Data quality for vascular risk markers collected from GP databases: Fasting triglycerides; fasting glucose; markers of microvascular disease (microalbuminuria) Data quality for other outcomes collected at 6-month interview | — |
Countries
United Kingdom
Outcome results
None listed