Title: Managing with Learning Disability and Diabetes
Funder: Department of Health (England)

Abstract: Phase I (Objectives 1-4)Design: Prospective case-finding survey. Setting: Three cities in West Yorkshire: Bradford Leeds and Wakefield. Target population: adults 17+years with type 2 diabetes who are not using insulin; mild to moderate LD defined by functional deficits (in extended ADL educational and social attainment and support needs day-to-day cognitive functions of memory and knowledge) attributable to primary or secondary (acquired) cognitive impairment. Exclusions: dementia severe mental illness alcohol dependence insufficient mental capacity to consent or to participate in diabetes self-management. Technologies: A simple checklist to enable staff working in primary care as they undertake QoF diabetes checks and in a range of other NHS and non-NHS settings to identify potential participants. We will then interview all potential participants to [a] identify those who meet entry criteria [b] establish current diabetes management including diet and physical activity levels; current physical health state from QoF measures (HbA1c BP BMI) [c] identify supporters and their role in diabetes management [d] elicit preferences for further assistance and potential for recruitment in a trial. In parallel and in collaboration with patient support groups people with LD and their supporters we will develop self-management materials - from existing literatures in LD and diabetes and chronic disease self-management and content of related care pathways such as that for obesity in LD. The manual will have selectable components to allow variable involvement with a supporter who may be eg currently shopping cooking or supervising meals. The manual will have a component for the patient for a supporter and for shared activities. At the same time we will develop an adherence measure (based upon knowledge and use of manual and relevant behaviour change) information and consent materials and undertake other set-up work for Phase II.Outcomes: Robust estimate of eligibility and characterisation of eligible population. Manual and adherence measureSample size: 350 to allow us to estimate proportion eligible to within 5% with 95% confidence.Phase II (objective 5)Design: Individually randomised feasibility RCT of manualised supported self-management versus treatment as usual.Target population: consenting adults identified in Phase I and supporters when presentTechnology: Manualised supported self-management of diabetes. The basic elements will be standardised but will be flexibly delivered: the professional support element may be via a diabetes specialist nurse hospital or community based. TAU= standard education materials from NHS sourcesOutcomes: recruitment rates; 6 months follow up rates. Variability of HbA1c; BMI; BP. data quality for other outcomes - Vascular risk markers: Fasting cholesterol; fasting glucose; Diabetes knowledge; self (and supporter) reported adherence to diet and activity. Distress (PHQ9). HRQL (SF12 and EQ5D); NHS and carer costs; Changes in treatment. Carer distress (PHQ9).Sample size: 80 randomised max 25% loss = 30/group in analysis .Timetable: M1-6 Phase I set-up; M7-21 identify & interview participants(QoF cycle=15m) M16-21 Phase II set up; M22-27 recruit to RCT; M28-33 FU; M34-36 analysis & write-up.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH;METABOLIC AND ENDOCRINE