- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01842984
Decreasing Loneliness in Older Adults (I-SOCIAL)
October 30, 2019 updated by: Professor Jiska Cohen-Mansfield, Tel Aviv University
Increasing Social Competence and Social Integration of Older Adults Experiencing Loneliness
The purposes of this study are: (1) decrease loneliness and social isolation and increase social competence and social integration of older adults experiencing loneliness; (2) examine an intervention process grounded in a theoretical model that was developed in a previous study.
The intervention process is tailored to the participants' barriers and abilities, and includes up to 10 personal meetings with an activities counselor and several group meetings.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tel-Aviv, Israel, 69978
- Tel-Aviv University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 65 or over
- residing in the Tel Aviv region
Exclusion Criteria:
- having known mental illness including schizophrenia, depression, bipolar disorder, and dementia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: I-SOCIAL intervention
Participants in this group will have up to 10 personal meetings with activities counselors and several group meetings.
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The I-SOCIAL intervention is based on findings from Cohen-Mansfield and Parpura-Gill (2007), which highlighted the important role of barriers in contributing to loneliness in older persons.
These barriers include a perceived lack of opportunities for social contacts, low social self-efficacy, and health and mobility difficulties.
The intervention includes: (1) identifying the barriers for the specific person; (2) up to 10 meetings with an activities counselor.
The meetings include discussions concerning options for social contacts and use of techniques and resources to tackle the barriers; and (3) group meetings of participants and the activities counselors in order to provide a concrete social event and as a venue to discuss barriers and ways to address them.
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NO_INTERVENTION: Control group
Participants in this group will not have meetings with the activities counselors, and will not take part in the group meetings.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Loneliness
Time Frame: Participants will be assessed before and after the intervention, an expected average of 6 months
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Loneliness will be assessed via several measures: (a) Frequency of loneliness will be measured via one item ("How often would you say you feel lonely?"; (Mullins, Woodland, & Putnam, 1990) on a 6-point scale from "never" (1) to "several times an hour" (6); (b) The UCLA Loneliness Scale- 8 items (ULS-8; (Hays & DiMatteo, 1987).
Each item is rated on a 5-point scale from "not at all" (1) to "to a great extent" (5), with a higher score indicating more loneliness.
Based on experience from another study (Cohen-Mansfield et al., 2013) one item ("I am unhappy being so withdrawn") was replaced with two items ("I feel physically distant from other people"; "I feel emotionally distant from other people).
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Participants will be assessed before and after the intervention, an expected average of 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jiska Cohen-Mansfiels, Professor, Tel Aviv University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (ACTUAL)
December 1, 2016
Study Completion (ACTUAL)
December 1, 2018
Study Registration Dates
First Submitted
April 22, 2013
First Submitted That Met QC Criteria
April 25, 2013
First Posted (ESTIMATE)
April 30, 2013
Study Record Updates
Last Update Posted (ACTUAL)
October 31, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 300009673
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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