NCT01754753

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. 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. 2.Determine if there is any lasting impact upon mental wellbeing by repeat measurement with all participants 12 months following baseline measurement
  3. 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. 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

57
Monitor

Trial Health Score

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

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

February 1, 2021

Completed
Last Updated

February 23, 2021

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

December 12, 2012

Results QC Date

January 11, 2021

Last Update Submit

February 4, 2021

Conditions

Keywords

Mental well-beingBefriending

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 COMPARATOR

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

Usual health and social care

NO INTERVENTION

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.

Interventions

Telephone friendship groups

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Study Sites (1)

The University of Sheffield

Sheffield, S1 4DA, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Results Point of Contact

Title
Daniel Hind - Assistant Director Sheffield Clinical Trials Research Unit
Organization
The University of Sheffield

Study Officials

  • Gail A Mountain

    University of Sheffield

    PRINCIPAL INVESTIGATOR

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

Locations