Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Mental Health Wellness 1
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study will employ a randomised waitlist trial design with mixed methods using a co-productive participatory approach.Masking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This trial will employ a randomised wait-list control design. The study has been co-designed with the research team at University of South Wales, Mind Cymru, the link workers and General Practioners working within the study sites. The study will assess the effectiveness of services provided through ...

This trial will employ a randomised wait-list control design. The study has been co-designed with the research team at University of South Wales, Mind Cymru, the link workers and General Practioners working within the study sites. The study will assess the effectiveness of services provided through making three sets of comparisons (based on a set of individual- and service-level outcomes over time - comparing between: - The four Local Mind sites (Merthyr and Valleys, Vale of Clwyd, Brecon and District, Ystradgynlais)? Those who complete the intervention immediately, with those who are in the waitlist group? Those who fully complete the social prescribing intervention with those who do not complete or partially the full social prescription but receive care as usual (either because they do not attend or only partially attend)? and Participants will be randomly allocated to receive the social prescribing link worker intervention either immediately, or after a waiting period of 20 working days. Participants will be recruited through consultations with healthcare professionals, either their General Practioner, a practice nurse or the Total Nurse Triage system within the doctors surgery. If the healthcare professional identifies that the prospective participant meets the eligibility criteria of the study (experiencing mild/moderate mental health and/or emotional wellbeing disorders, aged 18+ and registered with a General Practioners in Wales), they will provide the prospective participant with an information pack, and ask for permission to contact. If this permission is given they will be subsequently contacted by the link worker at least 2 working days later, to gain verbal consent and for baseline data collection and randomisation. The study recruitment target is 1,000 participants, randomized into two groups (a control group, n = 500 and an intervention group n = 500). The sample collected across the 3 General Practice clusters over the 24-month period that the study is open. An attrition rate of 5% is expected. Recruitment will end after 18-months, allowing for 6 months to complete the study and follow-up on participants. The service may continue independently of the study. Data will be collected at a maximum of five time points: Prior to randomisation to either the immediate or wait-list arm For wait-list controls: in a reminder telephone call at the end of the 20 day wait At the end of their intervention with the link worker Four weeks after the end of their intervention with the link worker Three months after the end of the previous data collection point Data will be collected either over the telephone or during the intervention with the link workers. All link workers who are collecting data will have study specific training for receiving consent and data collection. The study will take place over a 24-month period, with participant recruitment lasting a total of 18-months. Data analysis will take place at the end of the 24-month period, although transfer of data from the link workers to the research team at University of South Wales will be continuous over the 24-month period. A final report will be produced at the end of the study for the Welsh Government.

Tracking Information

NCT #
NCT04062903
Collaborators
MIND Cymru
Investigators
Study Director: Mark Llewellyn University of South Wales