Condition category
Signs and Symptoms
Date applied
13/03/2017
Date assigned
14/03/2017
Last edited
14/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
In developed countries approximately 25-55% of people at the age of 60 have two or more long-term health conditions (multiple chronic conditions). Having two or more long-term conditions can negatively impact on people’s lives and can lead to disability, poor quality of life and frailty. These problems are made worse with age, social deprivation and with people from Black and Minority ethnic backgrounds. A team of clinicians and researchers at the University Hospitals of Leicester have developed a group education programme (MAP programme) which aims to help people to manage their long-term health problems. The aim of this study is to evaluate the effectiveness of MAP in helping people with two or more long-term health conditions.

Who can participate?
Adults aged 40-85 who have two or more long-term health conditions and access to a mobile phone.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in the MAP programme. This involves attending four sessions lasting around 1.5 hours each, spaced two weeks apart. The sessions are led by a trained facilitator and involve discussions about being active, managing emotions, treatments and communications. After the first education session participants are sent a series of automated motivating text messages. Those in the second group continue as usual for the duration of the study. At the start of the study and then after six and 12 months, participants in both groups complete questionnaires and assessments to assess how active they are, how well they are managing their conditions and quality of life.

What are the possible benefits and risks of participating?
Whilst no direct benefits can be guaranteed, it is hoped that taking part in the study will still be a positive experience for those who attended. Half of the participants will attend the MAP programme, and, in addition, both groups will receive a health check during their clinic visits. There are no notable risks involved with participating.

Where is the study run from?
Leicester Diabetes Centre (UK)

When is the study starting and how long is it expected to run for?
November 2014 to December 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Helen Dallosso
helen.dallosso@uhl-tr.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Helen Dallosso

ORCID ID

Contact details

Broadleaf Wing
Leicester Diabetes Centre
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
+44 116 2584738
helen.dallosso@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33099

Study information

Scientific title

Promoting physical activity through group self-management support for those with multimorbidity: a randomised controlled trial

Acronym

MAP

Study hypothesis

The aim of this study is to evaluate the effectiveness of a structured education programme designed to help people with two or more long-term health conditions.

Ethics approval

West Midlands - South Birmingham Research Ethics Committee, 16/01/2017, ref: 16/WM/0505

Study design

Randomised; Interventional; Design type: Treatment, Education or Self-Management

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Primary Care, Primary sub-specialty: Health services and delivery research; UKCRC code/ Disease: Other/ General symptoms and signs

Intervention

After recruitment participants will be randomly assigned to two groups in a 1:1 ratio, statified by gender (men; women), and ethnicity (White European; other)

Intervention group: Participants will be invited to attend a group structured education programme - the MAP programme. They will also receive regular motivational text messages during the study period. The MAP programme consists of four sessions which last approximately 1.5 hours each and are two weeks apart. The sessions focus on personalised goal setting to increase physical activity and health related self-management activities, which impact on quality of life. Short motivational text messages will be sent to participants following the first education session. The text messages will be automated, unidirectional and will incur no charge to participants. The messages are motivational and will promote health behaviour change. The MAP education sessions will commence within approximately one month of recruitment. Participants will attend four education sessions. There will be approximately two weeks interval between the sessions. Short text messages will start soon after the first education session and will last up to the 12 month clinical assessment of participants. The frequency of the text messages will vary throughout the follow up period, i.e. up to the 12 month visit.

Control group: Participants will continue receiving their routine care in line with their clinical care team recommendations, i.e. there will be no change in their routine care.

Participants in both groups will be followed up for 12 month: they will be invited for clinic assessment and data collection. This will conclude participation to the study.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Average daily physical activity is measured using an accelerometer and physical activity questionnaires (RPAQ and SEE) at baseline and 12 months

Secondary outcome measures

1. Self-efficacy for managing chronic disease and exercise is measured by Chronic Disease Self-efficacy Scales at baseline, 6 and 12 months
2. Medication adherence is measured by The Morisky Medication Adherence scale (MMAS-8) at baseline and 12 months
3. Quality of life is measured using the HADS and EQ-5D-5L questionnaires at baseline and 12 months
4. Lifestyle behaviours other than physical activity will be measured by food intake and sleeping pattern questions at baseline and 12 months

Overall trial start date

01/11/2014

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Good understanding in written and verbal English
2. Able to give informed consent
3. 40-85 years old inclusive
4. Have two or more chronic conditions
5. Have access to a mobile phone for use in potential study activities
6. Able to walk independently

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 290; UK Sample Size: 290

Participant exclusion criteria

1. Limited understanding of written and verbal English
2. Dementia, learning disability, mental health disorders other than depression or epilepsy
3. Palliative care
4. Pregnancy
5. Currently participating or participated in another interventional trial in the previous 12 weeks
6. Patients with frailty. The definition of frailty will be at the investigator’s discretion and based on patients:
6.1. Living in care homes or institutions
6.2. Having support for daily activities such as washing, cooking, household tasks etc.
6.3. Having had unintentional significant weight loss in the last 3-6 months
6.4. Having BMI less than 18.5kg/m2

Recruitment start date

16/04/2017

Recruitment end date

31/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Diabetes Centre
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

University of Leicester

Sponsor details

Research & Enterprise Division
Research Governance Office
Fielding Johnson Building
Leicester
LE1 7RH
United Kingdom
+44 116 258 4099
uosponsor@le.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Study results will be published in peer reviewed journals and presented at national and international conferences, with the intention of publishing around one year after the overall trial end date. A lay report summarising the results will be sent to participants and reports will also be sent to the funder.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes