Condition category
Not Applicable
Date applied
08/02/2018
Date assigned
13/02/2018
Last edited
13/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The NHS scores well internationally on access to health care, but access has been measured on methods likely to undersample the more disadvantaged. Social landlords have access to more disadvantaged groups and may be able to improve health outcomes for their tenants and reduce their NHS usage by simple interventions. The aim of this study is to test whether provision of health information and signposting of services by housing association professionals to their tenants results in improved health and wellbeing outcomes.

Who can participate?
London social housing ‘general needs’ tenants aged over 50

What does the study involve?
Participants are given a health assessment then randomly allocated into a control group or one of two intervention groups. The control group receive no interventions. The 'signposting' group receive advice from the Neighbourhood Manager (a frontline staff member responsible for managing a group of properties). The treatment group receive an intensive 'hand-holding' service from a specialised team of health and wellbeing support workers to put them in contact with appropriate care and support providers. Participants are followed up over 18 months and changes in health outcomes and NHS usage are measured.

What are the possible benefits and risks of participating?
The interventions may support residents to engage with other services in their local area and offer general advice on health conditions aiming to help them understand and manage their health. No risks are anticipated as none of the services offered have any adverse effects on health.

Where is the study run from?
Family Mosaic (UK)

When is the study starting and how long is it expected to run for?
April 2012 to January 2016

Who is funding the study?
1. Family Mosaic (UK)
2. Economic and Social Research Council (UK)

Who is the main contact?
Prof. Stephen Gibbons

Trial website

Contact information

Type

Public

Primary contact

Prof Stephen Gibbons

ORCID ID

Contact details

London School of Economics
London
WC2 2AE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FM0001

Study information

Scientific title

Trial of health information interventions for samples of housing association tenants in London

Acronym

Study hypothesis

To test whether provision of health information and signposting of services by housing association professionals to their tenants resulted in improved health and wellbeing outcomes.

Ethics approval

London School of Economics Research Ethics Committee, 01/02/2013

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

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

Condition

General health

Intervention

Participants were given a baseline health assessment, after which participants found to have serious untreated health conditions were withdrawn to receive intensive treatment. The remaining pool of 532 participants was randomised into into two treatment groups (intensive and non intensive) and one control group:
1. A control group which received no intervention
2. A 'signposting' group which received advice from the Neighbourhood Manager (a frontline staff member responsible for managing a group of properties)
3. A treatment group which received an intensive 'hand-holding' service from a specialised team of health and wellbeing support workers to put tenants in contact with appropriate care and support providers

The entire process of random number generation and assignment was carried out through an automated function in the data entry system. A restricted randomisation was used, with stratification by age (over and under 70) and gender. No blocking was used.

Participants were followed up over 18 months and changes in health outcomes and NHS usage were measured.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Measured at baseline assessment, a 9-month intermediate assessment, and a final 18-month assessment:
1. Self-reported health outcomes: general health rating measured using a 5-point Likert scale, average health rating (asked at beginning and end of survey, average of these taken) measured using a 0-10 numeric scale
2. Mental wellbeing, measured using ONS Wellbeing measure, Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS), Loneliness on a 0-10 numeric scale
3. NHS usage: planned GP appointments, emergency GP appointments, planned hospital appointments, Accident and Emergency attendances, and nights in hospital in the last 6 months
4. Number of falls in the last 6 months
5. Self-reported activity and mobility ratings, measured on a 0-10 numeric scale
6. Health behaviours: completion of breast cancer tests, completion of cervical cancer tests, completion of bowel cancer tests, smoking levels, alcohol consumption, completion of blood pressure test

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/04/2012

Overall trial end date

01/01/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Tenants of Family Mosaic, over 50 years of age

Participant type

Healthy volunteer

Age group

Senior

Gender

Both

Target number of participants

600

Participant exclusion criteria

Tenants found to have serious health conditions

Recruitment start date

01/03/2013

Recruitment end date

01/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Family Mosaic
London
E1 2RJ
United Kingdom

Sponsor information

Organisation

Family Mosaic

Sponsor details

Albion House
20 Queen Elizabeth Street
London
SE1 2RJ
United Kingdom

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Family Mosaic

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Economic and Social Research Council

Alternative name(s)

ESRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Documentation on the trial is available from the authors or Family Mosaic, on request. The research article is accepted for publication, subject to obtaining a retrospective registration for the randomised control trial.

IPD sharing statement
The data is disclosive as it reveals residents' addresses and health conditions. Permission was obtained from participants for anonymised data sharing for research purposes. The data can be made available on request, in an anonymised format, by arrangement with Family Mosaic.

Intention to publish date

13/05/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes