Clinical trial NCT01754753: Putting Life in Years (PLINY): Telephone Friendship Groups Research Study
Official title: Evaluation of the Effectiveness and Cost Effectiveness of an Intervention to Promote Mental Wellbeing in Community Living Older People.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Self Efficacy
Loneliness
Keywords: Mental well-being
Befriending
Lead sponsor: University of Sheffield
Sponsor class: OTHER
Collaborators: name: University of Southampton
name: Northumbria University
name: Bangor University
name: Age UK
name: Community Network
First posted: 2012-12-21
Enrollment: 157
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Background and study aims:

People are living longer and many experience a good old age. Unfortunately longer life is not always accompanied by health and wellbeing. Older people can become lonely, isolated and unhappy as a result of a whole number of factors such as diminished physical abilities and bereavement.

Our research programme is examining how people aged 75 years and over can be helped to retain wellbeing and not feel unhappy due to feelings of loneliness and isolation. It is examining the possible benefits of group friendship over the telephone. Telephone befriending services are usually provided through the voluntary sector and are available in a number of locations. Befriending can take place on a one-to-one basis or through small groups of people linked together by telephone (teleconferencing). A small amount of research has already been conducted into telephone befriending. It appears to provide benefit but intevestigators need evidence from more people who have experienced befriending by telephone to be able to make clear statements about whether it should be recommended.

What does the study involve? To ensure that the research is thorough investigators want to recruit and involve 248 older people aged 75 years and over who live in Sheffield. It will take us over a year to recruit the number of older people investigators need as the befriending services can only accommodate a certain number of people at any one time.

The main method of inviting people to participate in the research is through letters of invitation from primary care. However investigators are also using other ways to get the information to those who might be interested such as giving talks at community venues and asking health and social care professionals to identify people who they think might benefit.

Everyone who has volunteered and is eligible to take part is randomly allocated to one of two groups. Not everyone will receive the research intervention (telephone friendship). Everyone is then asked questions about their wellbeing and health when they first meet a researcher and once again six months later. The investigators will compare the results from responses collected at the start of the study with the results collected six months later. The investigators will look to see whether those involved in telephone friendship groups feel happier about their lives compared with the group who were allocated to help in the research by answering questions only. To find out whether there might be any lasting benefit investigators will then ask all participants the same questions for a final time about 12 months after the start.

Those people allocated to receive telephone friendship will firstly receive up to six one-to-one calls from a trained and Criminal Records Bureau (CRB) checked Age UK Sheffield volunteer. The volunteer will talk to the participant for approximate 20 minutes and introduce them to the idea of group discussions over the telephone. They will then be invited to join a telephone friendship group with around six to seven other people. The friendship group then talk once a week for about one hour for 12 weeks with the group being assisted by an Age UK Sheffield volunteer.

As telephone friendship/ befriending services are relatively new, the investigators will look to see how they are being delivered and how people experience the service by talking with a small number of people have participated in the telephone friendship group. The investigators will also interview the Age UK Sheffield volunteers to find out if the telephone friendship service delivered to older people was as the investigators intended.

Older people are also helping us with the management of the study and continue to give their views on the progress of the project and any information that is being prepared. This is helping the researchers to ensure that what investigators ask people to do and any written material produced can be easily understood and meets the needs and expectations of those who are invited to take part.

Where is the study run from? The study is being organized by the University of Sheffield in partnership with Age UK and Community Network.

When is study starting and how long is it expected to run for? The study started on 1 October 2012 with invitations to join the study starting in June 2012 and continuing until May 2013. The study will run until December 2014 to enable us to follow-up participants, analyze the results and write a report of our findings.

Who is funding the study? National Institute for Health Research (NIHR), Public Health Research programme.

Eligibility 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

Primary outcomes:
measure: SF-36 Mental Health Dimension
timeFrame: SF36 at 6 months
Secondary outcomes:
measure: Other Dimensions of the SF-36 (and Specifically Physical Health)
timeFrame: SF36 other dimensions at 6 months
measure: EQ-5D for Health Economic Analysis
timeFrame: EQ-5D at 6 months
measure: General Perceived Self Efficacy (GSE) Scale
timeFrame: GSE at 6 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: PHQ-9 at 6 months
measure: De Jong Loneliness Scale
timeFrame: De Jong at 6 months
measure: ONS Wellbeing Question
timeFrame: ONS wellbeing at 6 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: The University of Sheffield
Study officials:
affiliation: University of Sheffield
name: Gail A Mountain
role: PRINCIPAL_INVESTIGATOR
References: