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

20. ledna 2016 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

930

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Leicester, Spojené království, LE5 4PW
        • Diabetes Research Centre, University of Leicester

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 74 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Glycosylated haemoglobin (HbA1c)
Časové okno: Baseline screening appointment
Identification of type 2 diabetes, impaired glucose regulation, or normal glucose regulation
Baseline screening appointment
Plasma glucose
Časové okno: Baseline screening appointment
Identification of type 2 diabetes, impaired glucose regulation, or normal glucose regulation
Baseline screening appointment

Sekundární výstupní opatření

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. února 2013

Primární dokončení (Aktuální)

1. září 2015

Dokončení studie (Aktuální)

1. září 2015

Termíny zápisu do studia

První předloženo

29. července 2015

První předloženo, které splnilo kritéria kontroly kvality

30. července 2015

První zveřejněno (Odhad)

31. července 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

21. ledna 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. ledna 2016

Naposledy ověřeno

1. července 2015

Více informací

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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