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| [ Print-friendly version ] |
| Looking after yourself when you have diabetes |
| ISRCTN | ISRCTN41897033 |
| DOI | 10.1186/ISRCTN41897033 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Looking after yourself when you have diabetes |
| Scientific title | Managing with learning disabilities and diabetes (feasibility study) |
| Acronym | N/A |
| Serial number at source | HTA: 10/102/03 |
| Study hypothesis |
This research involves two phases. In Phase I we will identify and characterise potential participants and develop a self-management manual and adherence measure. Phase II will be a feasibility Randomised Controlled Trial (RCT).
Phase 1: 1. Develop a manual to aid supported self-management of diabetes 2. Assess the feasibility of delivering the intervention 3. Develop a simple measure of adherence to the manual 4. Develop procedures for determining and recording capacity and obtaining consent Phase 2: 1. Estimate recruitment and retention rates to inform a definitive trial. 2. Assess the feasibility of collecting a range of outcome measures from participants and from medical records. 3. Test the effectiveness of the data collection forms developed 4. Assess the feasibility of delivering the intervention 5. Provide a detailed description of what treatment is delivered to each arm More details can be found at http://www.hta.ac.uk/2855 |
| Lay summary |
Background and study aims
This study involves people with learning disabilities who also have type 2 diabetes. There are high rates of poorly-controlled type 2 diabetes in adults with learning disability – this includes high levels of obesity and poor dietary habits; prescription medications that increase risk; and poor self-management skills. Finding those with diabetes, for service planning and for research purposes, is greatly facilitated in the UK by the fact that general practitioner’s (GPs) are required to maintain a register of all patients with diabetes. However, learning disability is less straightforward to define and identify, especially at the milder end of the spectrum. The intention of this study is thus, in phase 1, to develop and evaluate a simple case-finding method to identify participants who have both mild/moderate Learning Disability and Type 2 diabetes who are not taking insulin and who might be suitable for the study intervention. We also aim, in this phase to: • develop a manual to aid supported self-management of diabetes • assess the feasibility of delivering the intervention • develop a simple measure of adherence to the manual • develop procedures for determining and recording capacity and obtaining consent. Thereafter, we will conduct Phase 2 of the study. The aims of this are to: • estimate recruitment and retention rates to inform a definitive trial. • assess the feasibility of collecting a range of outcome measures from participants and from medical records. • test the effectiveness of the data collection forms developed • assess the feasibility of delivering the intervention • provide a detailed description of what treatment is delivered to each arm. This work will enable development of a large scale randomised controlled trial which will evaluate the clinical and cost-effectiveness of the intervention we develop. Who can participate? We will invite people who fit the following criteria to participate: Aged 18 and over, have type 2 diabetes which is not treated with insulin, have mild to moderate learning disability (not related to a disease acquired in adult life – e.g. adult-onset dementia), live in the community (not in a hospital setting). What does the study involve? The first phase of the study involves developing best methods for identifying eligible people, and then conducting interviews with consenting participants. The interview will include questions about how they currently manage their diabetes, consent for access to health care records, and identification of a supporter who might help them if they take part in the second phase of the study. We will also find out whether they would be interested in taking part in helping with the development of the intervention, and being involved in the second part of the study. The intervention will be ‘supported self-management’ materials, and will be developed by reviewing the literature and materials that are already in use to help people manage their diabetes. We will consult those participants who were willing to be involved in this process to further develop the intervention. In the phase 2 of the study participants will be randomly assigned to receive either the supported self-management intervention that has been developed in phase 1, or usual care. What are the possible benefits and risks of participating? We hope that some participants may benefit directly from the study materials. We anticipate very few risks to participants at any point in the study, but we will monitor to check on any changes in mood or behaviour. Where is the study run from? Diabetes services in primary and secondary care in Bradford, Leeds and Wakefield will be involved. The study researcher will be based at the University of Leeds. When is the study starting and how long is it expected to run for? We aim to commence recruitment to phase 1 in August 2013, phase 2 will commence recruitment for 6 months in November 2014 and will complete follow up in November 2015. Who is funding the study? The study is funded by the NIHR Health Technology Assessment Programme. Who is the main contact? Dr Louise Bryant l.d.bryant@leeds.ac.uk |
| Ethics approval | NRES Committee Yorkshire & The Humber - Humber Bridge, 09 July 2012, ref: 12/YH/0304 |
| Study design |
Phase 1 is a prospective case-finding survey & development of materials
Phase 2 individually-randomised feasibility Randomised Controlled Trial (RCT) |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Diabetes, Learning disabilities. |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/02/2013 |
| Anticipated end date | 31/01/2016 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 350 in phase 1, 80 in phase 2. |
| 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 and Outcomes Framework (QoF) diabetes checks 2. Self-management materials will be developed - from existing literatures in Learning Disability and diabetes and chronic disease self-management, and from content of related care pathways such as that for obesity in Learning Disability. The manualised self-management intervention will have selectable components to allow variable involvement with a supporter. It will have a component for the participant, for a supporter, and for shared activities 3. An adherence measure will be developed. Procedures: All potential participants will be interviewed to 1. Identify those who meet entry criteria 2. Establish current diabetes management and current physical health state from QoF measures 3. Identify supporters and their role in diabetes management 4. Elicit preferences for further assistance and potential for recruitment into Phase II. Interviews will then be conducted by the Study Researcher with the diabetes specialist nurses to identify any barriers to delivery. Phase 2 of the study, the randomised feasibility element. For those randomised to active intervention we will arrange the professional support element via a routine diabetes specialist nurse who will be hospital or community based. The nurse will introduce manualised supported self-management of diabetes to the person with diabetes and their supporter, explaining how to use the materials and suggesting some initial actions and activities. Further contact will be negotiated but we anticipate 2-3 further meetings of 30-60 minutes over the next 6-8 weeks, followed by telephone support and advice – the balance offered to the person with diabetes or their supporter to be decided by negotiation. Those randomised to usual treatment will receive standard education materials produced by the NHS, or charities such as Diabetes UK will be provided according to local service policy. Different nurses will be involved in providing the intervention and control. A single session with the diabetes specialist nurse will be arranged; a DVD may be provided. Little is currently known about the general level of care delivered at a local level. One of the objectives of Phase II will be to provide a detailed description of what is delivered to each arm, including a checklist of health care professionals involved, by centre and level (primary, secondary and third sector organisation), and a list of their associated tasks. We will talk to professionals about how their service operates and what difficulties or barriers they face. Follow-up at 6 months |
| Primary outcome measure(s) |
At the end of Phase I we will have:
1. A robust estimate of the numbers of people who meet our criteria, and the numbers willing to consider change and to participate in further research. 2. We will be able to 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. We will have developed our self-management materials and adherence measure and field-tested them for acceptability in a case series of six people. Phase 2 primary outcome: In the definitive trial we would use HbA1c 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 we will undertake 6 months follow up, which will be adequate for our main outcomes: 1. Variability of: 1.1. HbA1c 1.2. Blood pressure (BP) 1.3. Body mass index (BMI) 2. Recruitment rates 6 months follow up rates |
| Secondary outcome measure(s) |
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 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) ref: 10/102/03 |
| Trial website | |
| Publications | |
| Contact name | Prof Allan House |
| Address |
University of Leeds
Charles Thackrah Building 101 Clarendon Road |
| City/town | Leeds |
| Zip/Postcode | LS2 9LJ |
| Country | United Kingdom |
| Sponsor | University of Leeds (UK) |
| Address |
Governance
Woodhouse Lane |
| City/town | Leeds |
| Zip/Postcode | LS2 9JT |
| Country | United Kingdom |
| Sponsor website: | http://www.leeds.ac.uk/ |
| Date applied | 26/10/2012 |
| Last edited | 21/01/2013 |
| Date ISRCTN assigned | 21/01/2013 |
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