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

February 4, 2021 updated by: University of Sheffield

Evaluation of the Effectiveness and Cost Effectiveness of an Intervention to Promote Mental Wellbeing in Community Living Older People.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Sheffield, United Kingdom, S1 4DA
        • The University of Sheffield

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SF-36 Mental Health Dimension
Time Frame: SF36 at 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Other Dimensions of the SF-36 (and Specifically Physical Health)
Time Frame: SF36 other dimensions at 6 months
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 other dimensions at 6 months
EQ-5D for Health Economic Analysis
Time Frame: EQ-5D at 6 months
EuroQol-5D-3L (EQ-5D-3L) is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This ranges from 1 (good health) to - 0.56.
EQ-5D at 6 months
General Perceived Self Efficacy (GSE) Scale
Time Frame: GSE at 6 months
The General Perceived Self Efficacy (GSE) Scale is a 10-item questionnaire assessing a person's coping resources. Responses are made on a 4-point scale. Summing up the responses to all 10 items yields the final composite score with a range from 10 to 40. Higher scores indicate higher perceived general self-efficacy, lower scores indicate lower perceived general self-efficacy
GSE at 6 months
Patient Health Questionnaire (PHQ-9)
Time Frame: PHQ-9 at 6 months
The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ. It scores each of the 9 DSM criteria of MDD as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher scores indicate better outcome.
PHQ-9 at 6 months
De Jong Loneliness Scale
Time Frame: De Jong at 6 months
The de Jong Gierveld Loneliness Scale score is a measuring instrument for loneliness. The total scale score is the sum of the item scores, ranging from 0 (not lonely) to 11 (extremely lonely).
De Jong at 6 months
ONS Wellbeing Question
Time Frame: ONS wellbeing at 6 months
The Office for National Statistics Wellbeing Question is a standard question used by Office for National Statistics to examine subjective wellbeing of the general population in the UK, with questions grouped in three domains - (evaluative, experience and eudemonic). It is scored on a 0 to 10 scale with a higher score indicating better well-being.
ONS wellbeing at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sheffield

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Southampton
Bangor University
Northumbria University
Age UK
Community Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gail A Mountain, University of Sheffield

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09-3004-01
  • 28645428 (Registry Identifier: ISRCTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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