Trial Outcomes & Findings for Putting Life in Years (PLINY): Telephone Friendship Groups Research Study (NCT NCT01754753)
NCT ID: NCT01754753
Last Updated: 2021-02-23
Results Overview
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.
TERMINATED
NA
157 participants
SF36 at 6 months
2021-02-23
Participant Flow
Participant milestones
| Measure |
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).
Telephone Friendship groups
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
79
|
|
Overall Study
COMPLETED
|
26
|
30
|
|
Overall Study
NOT COMPLETED
|
52
|
49
|
Reasons for withdrawal
| Measure |
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).
Telephone Friendship groups
|
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.
|
|---|---|---|
|
Overall Study
Study close
|
43
|
44
|
|
Overall Study
Lost to Follow-up
|
9
|
5
|
Baseline Characteristics
Putting Life in Years (PLINY): Telephone Friendship Groups Research Study
Baseline characteristics by cohort
| Measure |
Telephone Friendship Groups
n=78 Participants
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).
Telephone Friendship groups
|
Usual Health and Social Care
n=79 Participants
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.
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
81.4 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
80.3 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
80.8 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
English/Welsh/Scottish/Northern Irish/British
|
74 participants
n=5 Participants
|
74 participants
n=7 Participants
|
148 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Any other white background
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Carribbean
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Irish
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Prefer not to say
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: SF36 at 6 monthsPopulation: Intention to treat
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.
Outcome measures
| Measure |
Telephone Friendship Groups
n=26 Participants
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).
Telephone Friendship groups
|
Usual Health and Social Care
n=30 Participants
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.
|
|---|---|---|
|
SF-36 Mental Health Dimension
|
77.5 units on a scale
Standard Deviation 18.4
|
70.7 units on a scale
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: SF36 other dimensions at 6 monthsPopulation: Intention to treat
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.
Outcome measures
| Measure |
Telephone Friendship Groups
n=26 Participants
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).
Telephone Friendship groups
|
Usual Health and Social Care
n=30 Participants
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.
|
|---|---|---|
|
Other Dimensions of the SF-36 (and Specifically Physical Health)
|
60.3 units on a scale
Standard Deviation 29.9
|
56 units on a scale
Standard Deviation 29.9
|
SECONDARY outcome
Timeframe: EQ-5D at 6 monthsPopulation: Intention to treat
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.
Outcome measures
| Measure |
Telephone Friendship Groups
n=26 Participants
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).
Telephone Friendship groups
|
Usual Health and Social Care
n=29 Participants
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.
|
|---|---|---|
|
EQ-5D for Health Economic Analysis
|
0.73 units on a scale
Standard Deviation 0.35
|
0.71 units on a scale
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: GSE at 6 monthsPopulation: Intention to treat
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
Outcome measures
| Measure |
Telephone Friendship Groups
n=26 Participants
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).
Telephone Friendship groups
|
Usual Health and Social Care
n=30 Participants
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.
|
|---|---|---|
|
General Perceived Self Efficacy (GSE) Scale
|
32.9 units on a scale
Standard Deviation 4.7
|
32.1 units on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: PHQ-9 at 6 monthsPopulation: Intention to treat
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.
Outcome measures
| Measure |
Telephone Friendship Groups
n=26 Participants
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).
Telephone Friendship groups
|
Usual Health and Social Care
n=30 Participants
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.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
|
3.1 units on a scale
Standard Deviation 4
|
3.6 units on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: De Jong at 6 monthsPopulation: Intention to treat
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).
Outcome measures
| Measure |
Telephone Friendship Groups
n=26 Participants
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).
Telephone Friendship groups
|
Usual Health and Social Care
n=30 Participants
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.
|
|---|---|---|
|
De Jong Loneliness Scale
|
3.5 units on a scale
Standard Deviation 3.4
|
3.3 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: ONS wellbeing at 6 monthsPopulation: Intention to treat
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.
Outcome measures
| Measure |
Telephone Friendship Groups
n=26 Participants
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).
Telephone Friendship groups
|
Usual Health and Social Care
n=30 Participants
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.
|
|---|---|---|
|
ONS Wellbeing Question
|
8 units on a scale
Standard Deviation 1.5
|
7.6 units on a scale
Standard Deviation 1.8
|
Adverse Events
Telephone Friendship Groups
Usual Health and Social Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Daniel Hind - Assistant Director Sheffield Clinical Trials Research Unit
The University of Sheffield
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place