Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/05/2018
Date assigned
25/05/2018
Last edited
24/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The number of people in the UK with type 2 diabetes (T2D) is expected to rise to six million by 2035. Poor diabetes control uses a great deal of NHS resources and can have severe impacts. It is important that people with T2D are given proper help. If no changes are made to the way T2D is treated, the costs to the NHS are estimated to be about £17 billion by 2035. It is very difficult for busy health professionals to provide the full range of support that is necessary. Health programmes that involve individuals and communities more directly in the management of their own health conditions and support them to adopt healthier behaviours can improve health and reduce NHS costs. Social prescribing is a form of support for people with long-term conditions like T2D. The aim of this study is to assess the effectiveness of a new programme that has been developed over eight years by local health and voluntary sector organisations with input from patients and the public. It involves referral to a trained ‘Link Worker’ who supports and empowers people with T2D to make healthier lifestyle choices, to improve their health, self-care and quality of life. People can access the programme through their GP surgery. On referral, the Link Worker will discuss healthier lifestyle options with each person individually and help them to plan positive health behaviour changes. Link Workers will also provide information about other community services, such as, walking groups, welfare rights or employment advice and support people to attend. The aim of this study is to assess the effect of the programme, how much it costs, and how it affects other family members and the wider community.

Who can participate?
Patients aged 40 to 74 with one or more long-term health conditions, including type 2 diabetes, living in an urban area of high socio-economic deprivation

What does the study involve?
Information is collected from GP records on 1,600 people who received the intervention and it is compared in three ways: (i) with people at GP practices which don’t have the intervention; (ii) with people from the same practice who are eligible but don’t take up the intervention, and (iii) people who entered the programme at the beginning with people who entered it later. The costs and effectiveness of the programme are compared to existing treatment to see whether the intervention is value for money compared to other treatments. Observations and interviews with people using the service are used to find out how they experience it, in order to find out what works, why it works and what does not work and why. During the study, a group of service users and Link Workers advises researchers on involving people with the study, participant information, what the findings mean and producing user-friendly information about the study. The results of the study will help decide whether this type of programme should be funded in the future.

What are the possible benefits and risks of participating?
The benefits and risks of taking part in the intervention are entirely separate from any benefits or risks from taking part in the evaluation. The effectiveness evaluation relies on analyses of routinely collected primary care data. As these data are supplied to the research team in anonymised form and stored in accordance with NHS compliant information governance procedures no risks are expected. The benefits of the evaluation will be the effect on future service provision rather than any specific benefit to current participants. Those people who have opted out of use of their health service data for the purpose of research will be identified through usual primary care procedures and their data will not be used as part of this evaluation.

Where is the study run from?
Newcastle University (UK)

When is the study starting and how long is it expected to run for?
April 2012 to November 2020

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

Who is the main contact?
Dr Suzanne Moffatt

Trial website

Contact information

Type

Public

Primary contact

Dr Suzanne Moffatt

ORCID ID

Contact details

James Spence Institute
Royal Victoria Infirmary
Newcastle University
Newcastle upon Tyne
NE1 4LP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Ways to Wellness effectiveness evaluation V1

Study information

Scientific title

Effectiveness of Ways to Wellness, a community-based social prescribing intervention, on people aged 40 to 74 with type 2 diabetes, living in an ethnically diverse socio-economically deprived urban area, using natural experimental methods to assess change differences in measures of health status and health behaviours, including health-care utilisation, between intervention recipients and three control groups, with cost-effectiveness and ethnography studies to assess impact

Acronym

WtW

Study hypothesis

Ways to Wellness social prescribing intervention will impact the health status and health behaviours, including health care utilisation of people with type 2 diabetes living in areas of socio-economic deprivation

Ethics approval

IRAS (London Committee), 04/04/2018, IRAS project ID 238970

Study design

Natural experiment with three comparison groups and associated ethnographic study

Primary study design

Observational

Secondary study design

Natural experiment

Trial setting

Community

Trial type

Prevention

Patient information sheet

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

Condition

Type 2 diabetes

Intervention

Participants with one or more long term health conditions, including type 2 diabetes, are offered the Ways to Wellness service and referred by their GPs in WtW participating practices. These practices number 17 of the 33 GP practices in the locality (city). There are no randomisation procedures. The allocation of GP practices to participate or not in the WtW service depends on the historical organisation of primary care services in the locality (city) where the study takes place.

Those who participate in the WtW service (intervention group) are allocated to a trained link worker, who is trained in behaviour change techniques and supports them to improve their health behaviours and to access other services relevant to their individual health and social needs. Ways to wellness link workers are employed by two not-for-profit community based organisations to deliver the intervention. Link workers are tasked to develop sustained, supportive relationships with people referred from primary care and they support their clients to identify goals and encourage goal achievement by linking them into community, voluntary and NHS sector services.There is no prescribed time scale for participant engagement in the service, but a period not exceeding 24 months is expected.

There are three comparison groups:
1. Comparison by time of engagement in the WtW service
2. Comparison with those in participating GP practices who are eligible for the WtW service, but who do not participate in the service over the duration of the study
3. Comparison with those who fulfil the individual eligibility criteria but are registered with non-participating) GP practices in the city

A team of university researchers will use a number of different research methods, known as ‘mixed methods’. In study one, information on 1,600 people from GP records will be compared in three ways: (i) with people in practices who don’t have the intervention; (ii) with people from the same practice who are eligible but don’t take up the intervention, and (iii) people who entered the programme at the beginning with people who entered it later. In study two, the costs and effectiveness of the programme will be compared to existing treatment to see whether the intervention is value for money compared to other treatments. In study three, observations and interviews with people using the service will be used to find out how they experience it. This will help us find out what works, why it works and what does not work and why. During the study, a group of service users and Link Workers will advise researchers on involving people with the study, participant information, what the findings mean and producing user-friendly information about the study.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The effectiveness study (work package 1) will assess change in measures of health status in the intervention group and three comparator groups. The primary outcome measure is short-term (one year) and long-term (two and three year) effects of Ways to Wellness intervention targeting adults with type 2 diabetes on changes in HbA1c. These data will be assessed using routinely collected primary care data. These data are collected as part of each participants usual health care and the timepoints when data are collected will vary with individual need. However, for the purpose of data extraction data will be used at quarterly intervals. The first data will be from three years before the first patient is recruited to the WtW service (three years prior to 01/04/2015) and up to 31/03/2020.

Secondary outcome measures

Weight, body mass index (BMI), systolic blood pressure (SBP) and total cholesterol values, smoking status and health-care utilisation, assessed using routinely collected primary care and secondary service user data. These data are collected as part of each participants usual health care and the timepoints when data are collected will vary with individual need. However, for the purpose of data extraction data will be used at quarterly intervals. The first data will be from three years before the first patient is recruited to the WtW service (three years prior to 01/04/2015) and up to 31/03/2020.

Overall trial start date

01/04/2012

Overall trial end date

30/11/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 40 to 74 years
2. One or more long term health conditions, including type 2 diabetes
3. Living in an urban area of high socio-economic deprivation
4. Community dwelling adults

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1600 intervention participants and similar numbers in each of the comparison groups

Participant exclusion criteria

1. People with end stage disease
2. The effectiveness analysis relies on routinely collected primary care data. people who have opted out of the use of their primary care data for research purposes will be identified by GP practices and their data will not be included in the study

Recruitment start date

01/04/2015

Recruitment end date

31/03/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle University
NE1 4LP

Sponsor information

Organisation

Newcastle University

Sponsor details

Kings Gate
Newcastle upon Tyne
NE1 7RU
United Kingdom

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

A study website and social media will be used to publicise the research to the widest possible audience. We will target key influencers and policy makers with written and oral presentations to a wide range of audiences including not-for-profit sector and health care organisations. Results will be made available to those using the service, Link Workers and community groups. Results will also be published in academic, practitioner and policy journals, and presentations will be given at national and international conferences. The trialists expect to publish a protocol paper within the next year and to publish outcome data from the effectiveness analysis in 2021. In the meantime information about the study will be available shortly on the NIHR website.

IPD sharing statement
The datasets generated and/or analysed during the current study are not expected to be made available by the research team as their use of these data relies on agreements with other parties and compliance with information governance procedures that do not provide them with permission to share these data.

Intention to publish date

31/12/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes