Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial of a community based volunteer visiting programme for older people experiencing loneliness
Acronym
Study hypothesis
To ascertain if a volunteer visitor scheme can improve mental and physical health of older people experiencing social isolation and loneliness
Ethics approval
Joint Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital and St Jamess Hospital Ethics Committee approved on 19/08/2011, Ref: 2010/31/01
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Loneliness and social isolation in older people
Intervention
1. 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 type
Behavioural
Phase
Drug names
Primary outcome measures
De Jong Gierveld Loneliness Scale measured pre and post intervention at one month and three month follow-up.
Secondary outcome measures
1. 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 trial start date
01/05/2011
Overall trial end date
31/01/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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)
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. 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
Recruitment start date
01/05/2011
Recruitment end date
31/01/2012
Locations
Countries of recruitment
Ireland
Trial participating centre
Mercer's Institute for Research on Ageing
Dublin
8
Ireland
Sponsor information
Organisation
Ageing Well Network (Ireland)
Sponsor details
16-17 College Green
Dublin 2
Dublin
2
Ireland
Sponsor type
Research council
Website
Funders
Funder type
Charity
Funder name
Atlantic Philanthropies (USA)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary