ISRCTN ISRCTN96259142
DOI https://doi.org/10.1186/ISRCTN96259142
Secondary identifying numbers FM0001
Submission date
08/02/2018
Registration date
13/02/2018
Last edited
02/08/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Stephen Gibbons
Public

London School of Economics
London
WC2 2AE
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleTrial of health information interventions for samples of housing association tenants in London
Study objectivesTo 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(s)London School of Economics Research Ethics Committee, 01/02/2013
Health condition(s) or problem(s) studiedGeneral health
InterventionParticipants 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 typeOther
Primary outcome measureMeasured 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 measuresThere are no secondary outcome measures
Overall study start date01/04/2012
Completion date01/01/2016

Eligibility

Participant type(s)Healthy volunteer
Age groupSenior
SexBoth
Target number of participants600
Total final enrolment547
Key inclusion criteriaTenants of Family Mosaic, over 50 years of age
Key exclusion criteriaTenants found to have serious health conditions
Date of first enrolment01/03/2013
Date of final enrolment01/03/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Family Mosaic
London
E1 2RJ
United Kingdom

Sponsor information

Family Mosaic
Charity

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

ROR logo "ROR" https://ror.org/04zj5v917

Funders

Funder type

Charity

Family Mosaic

No information available

Economic and Social Research Council
Government organisation / National government
Alternative name(s)
ESRC
Location
United Kingdom

Results and Publications

Intention to publish date13/05/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planDocumentation 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 planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2018 02/08/2019 Yes No

Editorial Notes

02/08/2019: Publication reference and total final enrolment number added.