NCT04124744

Brief Summary

This study is a pilot RCT to evaluate the effectiveness and implementation challenges of an intervention using volunteer 'Health Champions' matched with service users to support service their physical health goals.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

April 2, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

February 20, 2020

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

October 9, 2019

Last Update Submit

February 19, 2020

Conditions

SchizophreniaBipolar DisorderMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • EQ-5D-3L

    Physical health related quality of life measure-The descriptive system element of the EQ-5D questionnaire produces a 5-digit health state profile that represents the level of reported problems on each of the five dimensions of health. A higher score indicates poorer health. into a single summary number.

    Change in outcome from baseline at 9 months and 15 months

Secondary Outcomes (5)

  • Recovering Quality of Life Questionnaire-ReQOL

    Change in outcome from baseline at 9 months and 15 months

  • Patient Activation Measure

    Change in outcome from baseline at 9 months and 15 months

  • Multimorbidity Treatment Burden Questionnaire

    Change in outcome from baseline at 9 months and 15 months

  • De Jong Gierveld Loneliness Scale

    Change in outcome from baseline at 9 months and 15 months

  • Health screenings in last 6 months

    change in number of health screenings from baseline at 9 months and 15 months

Study Arms (2)

Intervention

EXPERIMENTAL

Will receive the Health Champion intervention

Other: Health Champions intervention

Control

ACTIVE COMPARATOR

Treatment as usual

Other: Control group-treatment as usual

Interventions

Health Champions interventionOTHER

Health Champions are trained volunteers who will support service users with their physical health goals over 9 months, meeting once a week

Intervention
Control group-treatment as usualOTHER

Participants will receive treatment as usual from their Community Mental Health Team

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years old with a serious mental illness (Mood \[affective\] disorders \[F30-F39\], Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders \[F20-F29\]).
  • Currently with a Community Mental Health Team (CMHT).
  • Want to make changes to their physical health.
  • Has capacity to give written informed consent to take part in the project.
  • Able to provide a named Care Coordinator or Point of Contact reachable in the event of a health crisis.

You may not qualify if:

  • Under 18 years of age
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

Location

Related Publications (1)

  • Williams J, Fairbairn E, McGrath R, Bakolis I, Healey A, Akpan U, Mdudu I, Gaughran F, Sadler E, Khadjesari Z, Lillywhite K, Sevdalis N. A feasibility hybrid II randomised controlled trial of volunteer 'Health Champions' supporting people with serious mental illness manage their physical health: study protocol. Pilot Feasibility Stud. 2021 May 31;7(1):116. doi: 10.1186/s40814-021-00854-8.

    PMID: 34059148DERIVED

MeSH Terms

Conditions

SchizophreniaBipolar DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersDepressive Disorder

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 11, 2019

Study Start

April 2, 2020

Primary Completion

January 30, 2022

Study Completion

May 30, 2022

Last Updated

February 20, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

Deidentified individual participant data for all primary and secondary outcome measures will be made available

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available within 6 months of study completion
Access Criteria
Data requests will be reviewed by the team. Requestors will be required to sign a Data Access Agreement.

Locations

GB(1)