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Diabetes Screening & Prevention for People With Learning (Intellectual) Disabilities:STOP Diabetes Study

2016년 1월 20일 업데이트: University of Leicester

Screening for Glucose Intolerance and Development of a Lifestyle Education Programme for Prevention of Type 2 Diabetes in a Population With Learning Disabilities

People with learning (intellectual) disabilities have more health problems than the rest of the population; they are less likely to access help and have lifestyles that may increase their risk of getting diabetes (for example, poor diet and lack of physical activity). People with learning disabilities may also be prescribed drugs or have certain medical conditions (such as Down's syndrome) which can make their chances of getting diabetes greater.

Diabetes is a long-term condition, which can cause damage to the eyes, heart, kidneys, nerves and feet. Impaired glucose regulation happens when sugar levels in the blood are higher than normal but are not high enough to be diagnosed with diabetes. People with impaired glucose regulation are more likely to develop diabetes, heart disease and stroke in the future. If people with impaired glucose regulation make changes to their lifestyle (diet and exercise) they can prevent or delay getting diabetes.

The aim of this study is to screen people with learning disabilities for diabetes and impaired glucose regulation. The investigators also want to find out the best way to give people with learning disabilities some education around healthy lifestyles (for example, eating and exercise) to help with prevention of diabetes and cardiovascular disease. Therefore, the investigators also aim to develop a lifestyle education programme that is suitable for use in this population and test whether it is feasible and acceptable.

연구 개요

상세 설명

Background -Adults with learning (intellectual) disabilities tend to have more health problems than the general population and are less likely to access help. Additionally, evidence suggests that due to a combination of lifestyle factors (e.g. poor diet, lack of physical activity), associated medical problems, and certain types of prescribed medication, people with learning disabilities may be at increased risk of developing type 2 diabetes and cardiovascular disease. Our overall aim is to undertake a programme of research that improves our knowledge and understanding of screening for impaired glucose regulation and type 2 diabetes in a population with learning disabilities, and to develop a lifestyle education programme for prevention of type 2 diabetes that is suitable for use in this population.

SCREENING PROGRAMME

Aim - The main programme of work consists of a large diabetes screening programme. The primary aim of the screening study is to evaluate the feasibility and clinical and cost effectiveness of a screening programme for identifying undiagnosed type 2 diabetes and impaired glucose regulation that is suitable for use in a population with learning disabilities.

Methods - A variety of approaches will be used to recruit people to the screening study: General practices will be approached first for participation in this study. If the practice does not agree, then the investigators will seek to approach eligible people on the Leicestershire Learning Disabilities Register. Learning disabilities consultants will also approach people face to face when attending for outpatient clinic appointments. Additionally, if individuals with learning disabilities (and/or their carer) contact the STOP Diabetes team to express an interest in the study, they will be given an invitation.

  • Volunteers will be asked to attend an appointment(s) where consent will be obtained and biomedical and demographic data collected. The consent process and data collection will be staged and people may need to attend between one to three appointments to complete.
  • People who are found to have type 2 diabetes or impaired glucose regulation will be asked to see their GP for care.
  • At every stage, reasonable adjustments will be made to take into account people's communication needs and decision making capacity. This may include involving a carer or a

DEVELOPMENT AND TESTING OF A STRUCTURED EDUCATION PROGRAMME

The aims of additional work being carried out alongside the screening study are to: (1) develop a lifestyle education programme to meet the needs of a population with learning disabilities and impaired glucose regulation or high risk of diabetes; (2) assess the feasibility of collecting outcome measures for participants with learning disabilities before and 3-months after they attend the education programme.

Methods - People approached to take part will be people who took part in the screening study and (1) gave their consent to be approached to take part in further phases of the research programme, and (2) were found to be at increased risk of developing diabetes according to their screening results.

Qualitative Interviews to inform curriculum development:

  • Interviews will be conducted with a sample of people with mild/moderate learning disabilities, their carers and healthcare professionals. Findings from the interviews will help inform development of an initial curriculum and education program.

Delivery of initial curriculum and obtaining feedback:

  • As part of the development work the education programme will be piloted with at least two groups of 6 - 8 people plus carers. Feedback will be collected from some of the people who attend the education sessions and any necessary changes made to the curriculum. These cycles of piloting, collecting feedback and modifying the programme will be repeated until the education programme developed is "fit for purpose".

Delivery of programme with collection of before and after measures:

  • Following initial development, testing and refinement of the curriculum, the education programme will be delivered with another sample of participants and the feasibility of collecting pre and post intervention outcome measures will be tested. The investigators anticipate delivering the programme to up to two groups of 6 - 8 people plus carers. Data will be collected at baseline and 3-months (12 weeks) following delivery of the final education session. Data and may include: physical activity and sedentary behaviour (as measured by accelerometer); body weight, BMI, waist circumference, blood pressure and dietary intake (fruit and vegetables). Uptake of the education programme (attendance) and retention at 3-months follow-up will also be explored. This phase will be subject to modification depending on the findings from prior iterations and any problems encountered.

연구 유형

관찰

등록 (실제)

930

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Leicester, 영국, LE5 4PW
        • Diabetes Research Centre, University of Leicester

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Adults with a learning (intellectual) disability who are live in Leicester, Leicestershire or Rutland, UK;

설명

Inclusion Criteria:

  • Volunteer has a confirmed learning disability (permanent intellectual impairment);
  • Registered with a general practice in Leicester, Leicestershire or Rutland, UK;
  • Participant and/or carer has sufficient English language skills to enable fully informed consent to be obtained.

Exclusion Criteria:

  • Confirmed diagnosis of Type 2 diabetes or Type 1 Diabetes;
  • Malignancy or terminal illness;
  • Pregnancy or breast feeding;
  • Severe systemic disease that may interfere with measurement and interpretation of HbA1c.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Glycosylated haemoglobin (HbA1c)
기간: Baseline screening appointment
Identification of type 2 diabetes, impaired glucose regulation, or normal glucose regulation
Baseline screening appointment
Plasma glucose
기간: Baseline screening appointment
Identification of type 2 diabetes, impaired glucose regulation, or normal glucose regulation
Baseline screening appointment

2차 결과 측정

결과 측정
측정값 설명
기간
Physical activity levels (including sedentary behaviour)
기간: Baseline screening appointment
measured by accelerometer - only for a small sub-group
Baseline screening appointment
Obesity levels
기간: Baseline screening appointment
body mass index and waist size
Baseline screening appointment
Blood pressure
기간: Baseline screening appointment
systolic and diastolic
Baseline screening appointment
Lipids levels
기간: Baseline screening appointment
total cholesterol, LDL, HDL, triglycerides
Baseline screening appointment
Dietary/nutritional intake
기간: Baseline screening appointment
food groups and fruit and vegetable intake
Baseline screening appointment
Cardiovascular risk
기간: Baseline screening appointment
Framingham risk score
Baseline screening appointment
Health related quality of life
기간: Baseline screening appointment
EQ-5D
Baseline screening appointment
Behavioural disorders
기간: Baseline screening appointment
Aberrant Behaviour Checklist
Baseline screening appointment
Psychiatric disorders
기간: Baseline screening appointment
PAS-ADD checklist
Baseline screening appointment
Depression
기간: Baseline screening appointment
Glasgow Depression Scale and Carer Supplement
Baseline screening appointment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Prof Kamlesh Khunti, PhD, FRCGP, Diabetes Research Centre, University of Leicester
  • 수석 연구원: Prof Sabyasachi Bhaumik, FRCPsych, Learning Disability Service, Leicester Partnership NHS Trust

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 2월 1일

기본 완료 (실제)

2015년 9월 1일

연구 완료 (실제)

2015년 9월 1일

연구 등록 날짜

최초 제출

2015년 7월 29일

QC 기준을 충족하는 최초 제출

2015년 7월 30일

처음 게시됨 (추정)

2015년 7월 31일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 1월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 1월 20일

마지막으로 확인됨

2015년 7월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

제2형 당뇨병에 대한 임상 시험

구독하다