Condition category
Mental and Behavioural Disorders
Date applied
11/07/2011
Date assigned
19/10/2011
Last edited
10/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Gillian Paul

ORCID ID

Contact details

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

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 James’s 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

http://www.ageingwellnetwork.com/

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

Publication citations

Additional files

Editorial Notes

10/02/2016: Plain English summary added