Self EfficacyPLINYNCT01754753
Putting Life in Years (PLINY): Telephone Friendship Groups Research Study
A study testing Telephone Friendship groups in people with Self Efficacy and Loneliness, run by University of Sheffield at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self Efficacy, Loneliness
- What is being tested?
- Telephone Friendship groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
The research will also:
- 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.
- Determine if there is any lasting impact upon mental wellbeing by repeat measurement with all participants 12 months following baseline measurement
- 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.
- 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.
Read the 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.
- Conditions
- Self Efficacy, Loneliness
- Being tested
- Telephone Friendship groups
- Keywords
- Mental well-being, Befriending
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Friendship groupsOther
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: SF36 at 6 months
Secondary outcomes (6)
Other Dimensions of the SF-36 (and Specifically Physical Health)
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.
Measured: SF36 other dimensions at 6 months
EQ-5D for Health Economic Analysis
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.
Measured: EQ-5D at 6 months
General Perceived Self Efficacy (GSE) Scale
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
Measured: GSE at 6 months
Patient Health Questionnaire (PHQ-9)
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.
Measured: PHQ-9 at 6 months
De Jong Loneliness Scale
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).
Measured: De Jong at 6 months
ONS Wellbeing Question
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.
Measured: ONS wellbeing at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Due to lack of volunteer facilitators to deliver the intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton, Northumbria University, Bangor University, Age UK, Community Network
- Responsible party
- Sponsor
- Investigators
- Gail A Mountain, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754753
- Sponsor's protocol ID
- 09-3004-01
- Other IDs
- 28645428
- Acronym
- PLINY
- Status last verified
- May 2016
- First submitted
- 12 Dec 2012
- Last updated
- 23 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Cost Effectiveness of an Intervention to Promote Mental Wellbeing in Community Living Older People.
- ClinicalTrials.gov ID
- NCT01754753
- Acronym / sponsor ID
- PLINY / 09-3004-01
- Conditions
- Self Efficacy, Loneliness
- Keywords
- Mental well-being, Befriending
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of volunteer facilitators to deliver the intervention
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- University of Southampton, Northumbria University, Bangor University, Age UK, Community Network
- Study start
- Jun 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 1 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Determine if there is any lasting impact upon mental wellbeing by repeat measurement with all participants 12 months following baseline measurement
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone friendship groups | Active comparator | Other: Telephone Friendship groupsParticipants 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 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone Friendship groups | Other | Telephone friendship groups |
Primary outcome
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.
6 secondary outcomes
Other Dimensions of the SF-36 (and Specifically Physical Health)
Time frame: SF36 other dimensions at 6 months
EQ-5D for Health Economic Analysis
Time frame: EQ-5D at 6 months
General Perceived Self Efficacy (GSE) Scale
Time frame: GSE at 6 months
Patient Health Questionnaire (PHQ-9)
Time frame: PHQ-9 at 6 months
De Jong Loneliness Scale
Time frame: De Jong at 6 months
ONS Wellbeing Question
Time frame: ONS wellbeing at 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail A Mountain principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Friendship groups in people with Self Efficacy and Loneliness, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 Mental Health Dimension (time frame: SF36 at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.