Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/08/2014
Date assigned
11/09/2014
Last edited
23/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The need for structured education programmes for type 2 diabetes is considered to be very important for many governments around the world. One such national education programme in the UK is DESMOND. DESMOND has been shown to be successful for patients in general, but these programmes have not offered to people with intellectual disabilities (learning difficulties). We have adapted DESMOND for people with intellectual disabilities and type 2 diabetes to produce an amended programme known as DESMOND-ID. Here, we are doing a small scale, initial study (called a pilot trial) to see whether it is possible to test if DESMOND-ID is better at helping adults with intellectual disabilities to self-manage their diabetes than the original programme. In particular, we will see if using the programme leads to a fall in Hb1Ac (haemoglobin that has bound to glucose in the blood) levels, improve psychological well-being and quality of life, and promote a healthier lifestyle. This is important as the lack of appropriate structured education programmes and educational materials for people with intellectual disabilities can result in a number of other health problems and premature death.

Who can participate?
Adults with intellectual disabilities and type 2 diabetes, and their family/paid carers.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 attend the DESMOND-ID programme. Those in group 2 receive their usual routine care.

What are the possible benefits and risks of participating?
To our knowledge, this is the first study looking at a structured diabetes education for adults with intellectual disabilities which also involves their family/paid carers. NICE Diabetes Guidelines state that it is very important that people who have been diagnosed with type 2 diabetes should be offered a place on a structured education programme within 6 months to help them manage their condition and avoid complications. There are, therefore, significant benefits to be gained if adapting structured education programmes shown to work for the general population are beneficial for people with intellectual disabilities and other cognitive impairments. The trial will have both national and international relevance, helping to influence how governments and service providers support adults with intellectual disabilities and their family/paid carers to manage the persons’ type 2 diabetes.There are no potential risks involved in participating in this study.

Where is the study run from?
This is currently being decided upon: N Ireland (probably Antrim area), Scotland: Edinburgh, and Wales; Cardiff.

When is the study starting and how long is it expected to run for?
January 2015 to June 2015

Who is funding the study?
Diabetes UK

Who is the main contact?
Dr Laurence Taggart
l.taggart@ulster.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Laurence Taggart

ORCID ID

Contact details

Room 12J19
Institute of Nursing & Health Research
School of Nursing
University of Ulster
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
+44 (0) 2890366538
l.taggart@ulster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

A study protocol for a pilot randomised trial of a structured education programme (DESMOND-ID) for the self-management of type 2 diabetes for adults with intellectual disabilities (ID)

Acronym

DESMOND-ID

Study hypothesis

This protocol is for a pilot trial to determine whether a large-scale, randomised trial is feasible to test if DESMOND-ID is more effective than usual care in adults with intellectual disabilities for self-management of their type 2 diabetes (T2D), in particular as a means to reduce Hb1Ac, improve psychological well-being and quality of life, and promote a healthier lifestyle.

Ethics approval

HSC REC B, 29/10/2014, REC ref: 14/NI/1104

Study design

The study is a two arm, individually randomised, pilot trial in adults with ID and T2D, and their family/paid carers. It compares the DESMOND-ID programme with usual routine care.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Participants with ID will be screened for eligibility by the primary healthcare team or community ID nurse, who will provide the potential participants with a user friendly information sheet and consent form. Participants with a paid/family carer will be provided with an information sheet and consent form. It is only after consent has been obtained that the research team will contact the participant and family/paid carer to arrange baseline data collection.

Condition

Type 2 diabetes

Intervention

The DESMOND-ID programme is an amended version of the original DESMOND structured education programme that supports adults with T2D to self-manage their condition. The original DESMOND programme is based upon non-ID participants with T2D attending a six-hour education programme in a locality near them (i.e. hospitals, community centres, health centres, etc.), over one day or two-half days. A detailed description of how the DESMOND-ID intervention was developed and piloted is being currently written for publication which used the Template for Intervention Description and Replication (TIDieR) checklist and guide. The DESMOND-ID programme has an additional introductory education session that is held separately for the family/paid carers in order to support their understanding about T2D and how it is managed. Carers gain an understanding of how the DESMOND-ID programme works and their specific role in supporting the person with ID throughout the programme. The DESMOND-ID programme will be delivered in a day-centre or health centre, over six weeks with one session per week, lasting approximately two and a half hours. The participant with ID and their family/paid carer will be encouraged to attend the sessions together. The education sessions will be delivered by two trained educators who have been given two days training encompassing the DESMOND core newly diagnosed and DESMOND-ID programme training. These educators are likely to be health facilitators, community ID nurses, DSN or dieticians. Two educators will be trained in each of the three countries.

The educational intervention focuses on the concepts of self-management. The DESMOND programme is based upon the following theories:
1. Self-Regulation Theory (Leventhal) that focuses on individuals illness representations as a key determinant of their behavioural and emotional responses to illness
2. Social Learning Theory that focuses on individuals perceptions of their ability to carry out behaviours and support behaviour change through developing a personal action plan
3. Dual Process Theory that is used to guide the educational process of addressing individuals’ current understanding of diabetes. This process is used to actively engage participants in the learning process.

The educational content of the DESMOND-ID programme mirrors that of DESMOND. The way in which educators deliver this content is adapted to make it accessible for people with ID, and it covers:
1. What is diabetes
2. Food choices
3. Monitoring
4. Physical activity
5. Risks and complications and
6. Self-management plan

Each of the education sessions is composed of two 30-45 minute education sections with a break in the middle for refreshments. Previous work has shown that flexibility is required in delivery and timing of the education sessions in order to meet individuals’ concentration and learning needs.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

This pilot randomised trial will enable us to:
1. Examine the feasibility of delivering the DESMOND-ID programme
2. Assess eligibility, attendance levels, recruitment process, loss to follow-up, compliance and Hb1Ac of adults with ID and T2D
3. Determine the acceptability of randomisation to the adults with ID and their family/paid carers, using retention rates as a surrogate for acceptability
4. Determine the appropriateness and the acceptability of the outcome measures to the adults with ID through completion rates, in order to see whether the primary outcome measure (HbA1c) and secondary outcome measures (BMI, waist circumference, blood pressure, lipid profiles, CVD risk score, smoking, alcohol use, exercise, perceptions and severity of beliefs and quality of life) can be collected
5. Determine the appropriateness and the acceptability of the outcome measures for the family/paid carers through completion rates
6. Measure compliance of the trainers in delivering the DESMOND-ID programme
7. Estimate the treatment effect to determine whether this suggests a clinically important effect which will support the conduct of the full trial

Timepoints for all outcomes:
Baseline (Time 1): Jan/Feb 2015
Intervention: Feb 2015
Focus Groups: April/May 2015
Follow-up (Time 2): May/June 2015

Secondary outcome measures

N/A

Overall trial start date

26/01/2015

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years of age or older
2. Living in the community
3. Has mild/moderate ID and T2D identified in their clinical notes and by the ID team, GP, practice nurse and Diabetes Nurse Specialist (DSN)
The definition of a family/paid carer is someone who is either a family relative or residentialmember of staff who engages in the support of the person with ID. Verbal and/or written consent will be required from people with ID and from carers before they enter the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72 adults with ID and their family/paid carers

Participant exclusion criteria

1. Patients with type 1 diabetes
2. Patients with a severe/profound ID as assessed by the community ID team
3. Inability to communicate
4. Inability to give their verbal and/or written consent

Recruitment start date

26/01/2015

Recruitment end date

30/06/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Room 12J19
Newtownabbey
BT37 0QB
United Kingdom

Sponsor information

Organisation

University of Ulster (UK)

Sponsor details

c/o Mr Nick Curry
Research Governance Office
University of Ulster
Jordanstown Campus
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
+44 (0) 2890365131
n.curry@ulster.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Diabetes UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25872928

Publication citations

Additional files

Editorial Notes