Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with intellectual disabilities experience considerable health inequalities compared with the general population. They also have a different pattern of health needs, and their health needs are often not well met. To try to address this, the general practitioner contract in England and Wales has introduced payment to GPs if they conduct an annual health check with the adults with intellectual disabilities who are registered at their practice. Scotland did not introduce this, in view of the limited evidence on whether health checks are effective with this population. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a practice nurse led health check for adults with intellectual disabilities, compared with usual treatment only.

Who can participate?
Adults with intellectual disabilities aged 18 years and over, registered at the participating general practices.

What does the study involve?
All participants are interviewed and have their GP records inspected at the start of the study. They are then randomly allocated to either the health check group or the usual treatment group. Participants in the health check group are offered a health check with their practice nurse. This involves filling in a health questionnaire before the appointment, then discussing this with the nurse at the appointment, and answering some more health questions, having a selected physical examination and urine test. The usual treatment group do not have a health check, they just have their usual treatment. Three, six, and nine months after group allocation, participants have another interview, and at nine months, their GP records are inspected again.

What are the possible benefits and risks of participating?
If the health check is effective, then participants in that group will benefit from it. If it is effective, then at the end of the study, the participants in the usual treatment group will also be offered a health check with their practice nurse. If the health check is not effective, then there will be no personal benefit from taking part in the study, other than informing the evidence base for health care of others in the future.
We do not anticipate any side effects to the health checks, but participants and their carers will have to give up some time to have the health check, and also to talk to the researchers.

Where is the study run from?
60 general practices in the NHS Greater Glasgow and Clyde area will take part. The research team are based at the Institute of Health and Wellbeing at the University of Glasgow.

When is the study starting and how long is it expected to run for?
December 2010 to February 2013.

Who is funding the study?
The Scottish Government (UK).

Who is the main contact?
Professor Sally-Ann Cooper

Trial website

Contact information



Primary contact

Prof Sally-Ann Cooper


Contact details

University of Glasgow
Institute of Health and Wellbeing
Mental Health and Wellbeing Group
Gartnavel Royal Hospital
1055 Great Western Road
G12 0XH
United Kingdom
+44 (0)141 2110690

Additional identifiers

EudraCT number number

Protocol/serial number

Version 3

Study information

Scientific title

Practice nurse health checks for adults with intellectual disabilities: a randomised controlled trial



Study hypothesis

Health checks with practice nurses improve the detection and management of health needs, health monitoring needs, and health promotion needs of adults with intellectual disabilities.

Ethics approval

Research Ethics Committee - Scotland A, 25/11/2010, ref: 10/MRE00/79

Study design

Matched-pair cluster randomised controlled trial plus a cost-effectiveness study and a qualitative sub-study

Primary study design


Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Intellectual disabilities


Participants randomised to the intervention arm receive a health check with their practice nurse. The health check is a one-off procedure. It involves first the participant and their carer completing a health questionnaire, which they take with them to the appointment with the practice nurse. At the appointment with the nurse, the questionnaire is reviewed, and the nurse asks further health questions using the health check tool, completes a selected physical examination, and tests the participants urine. She then uses her clinical judgement and experience to follow through with any further appointments, investigations, or treatments that are clinically indicated, and can call upon the learning disabilities service if required.

Participants randomised to the treatment as usual group do not receive a health check or any intervention above their usual treatment.

Both study arms are followed up at 3, 6, and 9 months post randomisation.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Between group difference in the incidence of new health needs detected and new health needs being met during the 9 month period following randomisation (data from primary health care records interpreted at the blinded consensus meetings)

Secondary outcome measures

1. Between group difference in the extent of health monitoring needs being met (quality and outcome framework data from primary health care records)
2. Between group difference in the extent of health promotion needs being met (data from interview and primary health care records interpreted at the blinded consensus meetings)
3. Between group difference in the change in participant/carer rated general health (scores on SF-36 and EQ-5D)
4. Between group difference in costs (data from the client service receipt inventory)
5. Cost-effectiveness of the intervention compared with treatment-as-usual, in terms of cost per quality adjusted life year

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Adults with intellectual disabilities aged 18 years and over
2. Registered at one of the 60 participating practices

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Unable to obtain consent in keeping with the Adults with Incapacity (Scotland) Act (e.g. person delines, their relative declines, they do not have a relative or welfare guardian/attorney)
2. Terminal illness
3. The person's GP considers it inappropriate to invite the adult (e.g. due to family circumstances such as a recent death of a parent)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Glasgow
G12 0XH
United Kingdom

Sponsor information


NHS Greater Glasgow and Clyde (UK)

Sponsor details

c/o Dr Erica Packard
Research and Development Central Office
The Tennent Institute
Western Infirmary
38 Church Street
G11 6NT
United Kingdom
+44 (0)141 2116208

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Scottish Government - Change Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

2014 results in:

Publication citations

Additional files

Editorial Notes