ISRCTN ISRCTN76583833
DOI https://doi.org/10.1186/ISRCTN76583833
Secondary identifying numbers N/A
Submission date
11/07/2011
Registration date
19/10/2011
Last edited
10/02/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Social isolation and loneliness are common in older people and are associated with poor health outcomes, including depression, insomnia, lower quality of life, illness and death. In spite of the evidence supporting an association between health and social relationships there have been relatively few scientific studies in this area. This study aims to determine whether a short-term volunteer visiting programme for older people who experience loneliness can improve their mental and physical outcomes.

Who can participate?
People over 65 years of age from two counties in Ireland (Co. Meath and Co. Kilkenny) who feel lonely.

What does the study involve?
Participants are randomly allocated to the intervention group or the control group. Participants in the intervention group receive ten home visits over ten to twelve weeks from a volunteer visitor. The volunteer visitor is an older person who has been trained for the purposes of the study. The visits are social and informal with the aim of helping the older person think about improvements they would like to make in relation to contact with friends, family and their local community. Both the control and intervention participants have four home visits from a member of the research team to collect data. Two of these visits are before the start of the intervention and two after the intervention.

What are the possible benefits and risks of participating?
The research team does not anticipate any risks associated with participating in the study.

Where is the study run from?
Mercer's Institute for Research on Ageing (Ireland)

When is the study starting and how long is it expected to run for?
May 2011 to January 2012

Who is funding the study?
Atlantic Philanthropies (USA)

Who is the main contact?
Dr Gillian Paul

Contact information

Dr Gillian Paul
Scientific

Mercer's Institute for Research on Ageing
St James's Hospital
Dublin
8
Ireland

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised controlled trial of a community based volunteer visiting programme for older people experiencing loneliness
Study objectivesTo ascertain if a volunteer visitor scheme can improve mental and physical health of older people experiencing social isolation and loneliness
Ethics approval(s)Joint Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital and St James’s Hospital Ethics Committee approved on 19/08/2011, Ref: 2010/31/01
Health condition(s) or problem(s) studiedLoneliness and social isolation in older people
Intervention1. Participants in the intervention group will receive ten home visits from a volunteer visitor who has been trained for the purposes of the study
2. The visits are informal and social
3. Discussions between the participant and volunteer progress to focus on problem solving, and goal setting with the aim of assisting the participant in making a new social connection
Intervention typeBehavioural
Primary outcome measureDe Jong Gierveld Loneliness Scale measured pre and post intervention at one month and three month follow-up.
Secondary outcome measures1. Oslo Social Support Scale
2. Hospital Anxiety And Depression Scale (HADS)
3. 8-item Center for Epidemiologic Studies Depression Scale (CESD-8)
4. Control, Autonomy, Self realisation, Pleasure 19 scale (CASP 19)
5. Montreal Cognitive Assessment (MoCA)
6. Lubben Social Network Scale
7. Pittsberg Sleep Questionnaire
8. Body mass index (BMI)
9. Timed up and go
10. Grip strength

The outcomes will be measured pre and post intervention at one month and three month follow-up.
Overall study start date01/05/2011
Completion date31/01/2012

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants100
Key inclusion criteria1. Over 65 years of age
2. Living at home
3. Experiencing loneliness - must pass a screening test (score 3 or more on the 11 item De Jong Gierveld loneliness scale or answer ‘Yes’ when asked question 5 from the Center for Epidemiologic Studies Depression Scale)
Key exclusion criteria1. Have been socially isolated all their lives
2. Visual or hearing impairment severe enough to make social contact difficult or impossible
3. Require nursing assistance
4. Dementia, psychotic illness, alcohol misuse, any tendency to violence, or personality disorder
Date of first enrolment01/05/2011
Date of final enrolment31/01/2012

Locations

Countries of recruitment

  • Ireland

Study participating centre

Mercer's Institute for Research on Ageing
Dublin
8
Ireland

Sponsor information

Ageing Well Network (Ireland)
Research council

16-17 College Green
Dublin 2
Dublin
2
Ireland

Website http://www.ageingwellnetwork.com/

Funders

Funder type

Charity

Atlantic Philanthropies (USA)
Private sector organisation / International organizations
Alternative name(s)
The Atlantic Philanthropies, atlanticphil, Atlantic, The Atlantic Philanthropies (Bermuda) Limited, AP
Location
Bermuda

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

10/02/2016: Plain English summary added