Study Stopped
Due to lack of volunteer facilitators to deliver the intervention
Putting Life in Years (PLINY): Telephone Friendship Groups Research Study
PLINY
Evaluation of the Effectiveness and Cost Effectiveness of an Intervention to Promote Mental Wellbeing in Community Living Older People.
2 other identifiers
interventional
157
1 country
1
Brief Summary
The National Institute for Health Research commissioned this research with the following research question: "What is the relative effectiveness and cost effectiveness of home based support programmes in improving the mental wellbeing of older people living in their own homes?" The project will evaluate whether telephone friendship groups, delivered by the voluntary sector over the telephone, can improve the mental wellbeing of older people aged 75 or over. The research will also:
- 1.Identify the psychosocial and environmental factors, as well as implementation issues that may mediate or modify the effectiveness of the intervention using qualitative methods. This will include examining: 1.1. Assess voluntary sector readiness to take forward new forms of services; 1.2. The best modes of delivery of telephone support/friendship; 1.3. Assess how volunteers (facilitators) can be supported and retained; and, 1.4. The extent to which fidelity of the intervention is maintained within and across the participating organisations.
- 2.Determine if there is any lasting impact upon mental wellbeing by repeat measurement with all participants 12 months following baseline measurement
- 3.Examine whether there is any significant improvement on the physical dimension of the SF-36 at 6 months and 12 months, following baseline measure, for the intervention arm compared with usual care.
- 4.Measure the extent of use of health and social care, and community facilities by participants over time to determine whether the intervention is cost effective compared with usual care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 12, 2012
CompletedFirst Posted
Study publicly available on registry
December 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
February 1, 2021
CompletedFebruary 23, 2021
May 1, 2016
10 months
December 12, 2012
January 11, 2021
February 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SF-36 Mental Health Dimension
The Short Form 36 Health Survey Questionnaire (SF-36) is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.
SF36 at 6 months
Secondary Outcomes (6)
Other Dimensions of the SF-36 (and Specifically Physical Health)
SF36 other dimensions at 6 months
EQ-5D for Health Economic Analysis
EQ-5D at 6 months
General Perceived Self Efficacy (GSE) Scale
GSE at 6 months
Patient Health Questionnaire (PHQ-9)
PHQ-9 at 6 months
De Jong Loneliness Scale
De Jong at 6 months
- +1 more secondary outcomes
Study Arms (2)
Telephone friendship groups
ACTIVE COMPARATORParticipants allocated to telephone friendship groups will take part in 12 weekly group telephone discussions. The participant will be called, by a trained Age UK Sheffield volunteer, in their own home. The group discussions will take place for about an hour each week and involve between 6-8 participants. Participants will be introduced to weekly group calls by the volunteer who will call each participant individually for around 20 minutes each week for up to six weeks before the group is established. The group may have a particular focus or talk about different topics each week. The individual participants are joined together through a teleconferencing system (provided by Community Network).
Usual health and social care
NO INTERVENTIONParticipants allocated to the control arm will not receive any research intervention. However, they will participate in the research by completing questionnaires about their health and wellbeing.
Interventions
Eligibility Criteria
You may qualify if:
- Aged 75 years or over
- Good cognitive function, defined as Six Cognitive Impairment Test Brooke P, Bullock R, 1999) score of 7 or under;
- Living independently (including those who are co-resident with others) or in sheltered/ extra care housing;
- Able to understand and converse in English.
You may not qualify if:
- Aged 74 years or younger
- CIT score of 8 or more
- In residential/ nursing care homes
- Unable to understand and converse in English
- Unable to converse on the telephone with assertive technology 6. Already receiving a telephone intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sheffieldlead
- University of Southamptoncollaborator
- Northumbria Universitycollaborator
- Bangor Universitycollaborator
- Age UKcollaborator
- Community Networkcollaborator
Study Sites (1)
The University of Sheffield
Sheffield, S1 4DA, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniel Hind - Assistant Director Sheffield Clinical Trials Research Unit
- Organization
- The University of Sheffield
Study Officials
- PRINCIPAL INVESTIGATOR
Gail A Mountain
University of Sheffield
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2012
First Posted
December 21, 2012
Study Start
June 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
February 23, 2021
Results First Posted
February 1, 2021
Record last verified: 2016-05