Putting Life in Years (PLINY): Telephone Friendship Groups Research Study

This study has been terminated.
Sponsor:
Collaborators:
University of Southampton
Northumbria University
Bangor University
Age UK
Community Network
Information provided by (Responsible Party):
Professor Gail Mountain, University of Sheffield
ClinicalTrials.gov Identifier:
NCT01754753
First received: December 12, 2012
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention
Self Efficacy
Loneliness
Other: Telephone Friendship groups

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effectiveness and Cost Effectiveness of an Intervention to Promote Mental Wellbeing in Community Living Older People.

Resource links provided by NLM:


Further study details as provided by University of Sheffield:

Primary Outcome Measures:
  • SF-36 Mental health dimension [ Time Frame: Change from Baseline of SF36 at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other dimensions of the SF-36 (and specifically physical health) [ Time Frame: Change from Baseline in SF36 other dimensions at 6 months ] [ Designated as safety issue: No ]
  • EQ-5D for health economic analysis [ Time Frame: Change from Baseline in EQ-5D at 6 months ] [ Designated as safety issue: No ]
  • General Perceived Self Efficacy (GSE) Scale [ Time Frame: Change from Baseline in GSE at 6 months ] [ Designated as safety issue: No ]
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Change from Baseline in PHQ-9 at 6 months ] [ Designated as safety issue: No ]
  • De Jong loneliness scale [ Time Frame: Change from Baseline in De Jong at 6 months ] [ Designated as safety issue: No ]
  • Health and social care resource use [ Time Frame: Change from Baseline in resource use at 6 months ] [ Designated as safety issue: No ]
  • Telephone friendship group call costs question [ Time Frame: Change from Baseline in costs able/willing to pay at 6 months ] [ Designated as safety issue: No ]
  • ONS Wellbeing question [ Time Frame: Change from Baseline in ONS wellbeing at 6 months ] [ Designated as safety issue: No ]
    Standard question used by Office for National Statistics to examine subjective wellbeing of the general population in the UK.

  • Socio demographic questionnaire including a self report of health status [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 157
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Telephone friendship groups

Participants 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).

Other: Telephone Friendship groups
No Intervention: Usual health and social care
Participants 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Aged 74 years or younger
  • 6CIT 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754753

Locations
United Kingdom
The University of Sheffield
Sheffield, United Kingdom, S1 4DA
Sponsors and Collaborators
University of Sheffield
University of Southampton
Northumbria University
Bangor University
Age UK
Community Network
Investigators
Principal Investigator: Gail A Mountain University of Sheffield
  More Information

Additional Information:
No publications provided

Responsible Party: Professor Gail Mountain, Professor of Health Services Research (assisted living research), University of Sheffield
ClinicalTrials.gov Identifier: NCT01754753     History of Changes
Other Study ID Numbers: 09-3004-01, 28645428
Study First Received: December 12, 2012
Last Updated: March 22, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Sheffield:
Mental well-being
Befriending

ClinicalTrials.gov processed this record on September 18, 2014