Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
65 participants
INTERVENTIONAL
2019-10-01
2020-10-31
Brief Summary
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The study uses a waitlist trial, which means that some participants will get to meet the link worker and have the intervention straight away, while others will have to wait for 20 working days. From this, the researchers can compare the people who had the intervention straight away with the people who had to wait. Scores on well-being, quality of life and loneliness questionnaires will be used to see the effects of the intervention on patients, whilst information like patient attendance at the General Practioner surgery will be used to see if there is a difference in the patient's use of health services.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Immediate Appointment
Intervention group who receive the Social Prescription without delay. The effectiveness of the consultation and referral process will be assessed.
Immediate Appointment
The participant will meet with the MIND Cymru link worker and decide upon a course of action requiring the use of local services appropriate for the participant.
Delayed Appointment
Waitlist control group who receive social Prescribing after a delay of 20 working days. The effectiveness of the consultation and referral process will be assessed.
Delayed appointment
After a period of delay (Control) The participant will meet with the MIND Cymru link worker and decide upon a course of action requiring the use of local services appropriate for the participant.
Interventions
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Immediate Appointment
The participant will meet with the MIND Cymru link worker and decide upon a course of action requiring the use of local services appropriate for the participant.
Delayed appointment
After a period of delay (Control) The participant will meet with the MIND Cymru link worker and decide upon a course of action requiring the use of local services appropriate for the participant.
Eligibility Criteria
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Inclusion Criteria
* Experiencing mild/moderate mental health and/or emotional wellbeing disorders (e.g. anxiety or depression)
* Aged 18+ years
* Registered with a General Practioner in Wales
Exclusion Criteria
* Unable to answer all questions (WEMWBS and EQ-5D) at baseline
* Worsening of mental health condition to the point where more intensive support is required
18 Years
ALL
Yes
Sponsors
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MIND Cymru
UNKNOWN
University of South Wales
OTHER
Responsible Party
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Principal Investigators
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Mark Llewellyn
Role: STUDY_DIRECTOR
University of South Wales
Locations
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CTMUHB
Llantrisant, RCT, United Kingdom
Countries
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Other Identifiers
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IRAS260516
Identifier Type: -
Identifier Source: org_study_id
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