Condition category
Mental and Behavioural Disorders
Date applied
02/11/2016
Date assigned
18/11/2016
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with learning disabilities experience poor health in comparison to the general population. This study is trialing a computer tablet based app designed for adults with learning disabilities to enable information sharing between them and health practitioners. The My Health Guide app is intended to empower people with learning disabilities and provide them with greater control, as well as providing people who support them with information to enable them to better understand and connect. It is hoped this will enable people with learning disabilities to play an active role in their healthcare, through receiving and sharing health related information, in a range of formats appropriate to their communication needs and preferences. The aim of this study is to find out information about the contexts in which people with learning disabilities (and their supporters) are able to make successful use of My Health Guide and the usability of the app.

Who can participate?
Adults with learning disabilities who are users to the NHS learning disability service in Hull and the East Riding of Yorkshire and organisations working with them.

What does the study involve?
After agreeing to be part of the study, participants are given access to the App for approximately three months before they are asked about their experiences of using it. Participants are also able to keep the computer tablet they have been issued with and access to the App once the study has finished. A small number of participants are also invited to take part in interviews, focus groups or case studies as well as completing the questionnaire.

What are the possible benefits and risks of participating?
Participants may benefit from an improved ability to explain their needs and concerns, understand how to act on advice given to them and to share information. There are no notable risks involved with participating.

Where is the study run from?
Townend Court, Learning Disability Service (UK)

When is the study starting and how long is it expected to run for?
September 2015 to December 2016

Who is funding the study?
Small Business Research Initiative for Healthcare (UK)

Who is the main contact?
Mrs Patricia Bailey
trish.bailey1@nhs.net

Trial website

Contact information

Type

Public

Primary contact

Mrs Patricia Bailey

ORCID ID

Contact details

Humber NHS Foundation Trust
Townend Court
Cottingham Road
Hull
HU6 8QG
United Kingdom
+44 1482 336775
trish.bailey1@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

30775

Study information

Scientific title

My Health Guide – A non-randomised trial of a tablet application designed to support people with learning disabilities

Acronym

Study hypothesis

The aim of the study is to:
1. Understand the contexts in which people with learning disabilities (and their supporters) are able to make successful use of My Health Guide, and achieve positive outcomes, as well as contexts which impair use
2. Measure the extent to which participants adopt My Health Guide as a consistent approach to the management of their health

Ethics approval

North East - Newcastle & North Tyneside 2 Research Ethics Committee, 10/02/2016, ref: 16/NE/0016

Study design

Non-randomised; Interventional; Design type: Process of Care, Education or Self-Management, Management of Care

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Mental Health, Primary sub-specialty: Learning disorders; UKCRC code/ Disease: Mental Health/ Disorders of psychological development

Intervention

An overall sample size of 200 My Health Guide users is planned. Participants will be provided with access to the app following consent. After using the app for approximately 3 months, follow-up data will be collected in the participants’ place of residence, or in some cases their place of work, as follows:

Questionnaire
Participants will be given a questionnaire to complete (duration approx. 30 mins) designed specifically for this trial.

Semi-structured interviews
Interviews (duration approx. 1 hour) with 15 people, selected using purposive sampling, will be conducted to gain an in-depth understanding of their experiences of using the app. The interview guide has been developed specifically for the trial.

Case Studies
Five in-depth case studies will be conducted (duration approx. 1 hour per person). Potential case study participants will be selected on the basis that they are frequent users of the My Health Guide app or are using it in especially interesting, creative or unexpected ways.

Focus Groups
Focus groups (duration approximately 2 hours per group), using a guide developed specifically for this study, will be conducted with healthcare practitioners and independent care providers to collect data about their views and experiences, since they will be key users of the My Health Guide app, alongside people with learning disabilities.
Participants will be able to keep their computer tablet and access to the app once the study has finished.

Intervention type

Other

Phase

Drug names

Primary outcome measures

All outcome measures have been designed specifically for this study; no standard outcome measures are used and all are classed as primary outcomes.
1. Experience of using the My Health Guide app is measured using questionnaires, semi-structured interviews, case studies and focus groups in the participants’ place of residence, or in some cases their place of work
2. Usage of the app is measured using the backend usage data automatically collected remotely by the software provider

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2015

Overall trial end date

30/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18
2. People with learning disabilities who use the care planning process or who have a care plan in place
3. People with learning disabilities who are supported by named carers who implement the care planning process on their behalf, and who are not able to use My Health Guide themselves
4. People with learning disabilities living in settled accommodation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

Participant exclusion criteria

1. Under the age of 18
2. Not providing consent to participate (or their consultee has not agreed to this)
3. People are not living in settled accommodation (this is due to concerns that the provision of the tablet in this context
may increase their vulnerability)

Recruitment start date

01/02/2016

Recruitment end date

15/11/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Townend Court
Learning Disability Service Cottingham Road
Hull
HU6 8QG
United Kingdom

Sponsor information

Organisation

Maldaba Limited

Sponsor details

Olive House
32 Holmes Road
London
NW5 3AB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Small Business Research Initiative for Healthcare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Papers will be published in appropriate academic and health-related journals.

IPD Sharing plan:
Datasets will not be made available – this is due to reasons of confidentiality.

Intention to publish date

30/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes