Effectiveness of a Intervention to Reduce the Social Isolation and Loneliness of Elderly Residents at Home
NCT ID: NCT03345862
Last Updated: 2020-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
114 participants
INTERVENTIONAL
2018-05-15
2020-08-01
Brief Summary
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* Design: Clinical trial randomized by cluster, multicentric.
* Location: 14 health centers of the Andalusian Health Service (Spain).
* Subjects and methods: Subjects with social isolation. Age 65 or older. Residents in your home. Persons with cognitive impairment or dementia, difficulty in responding to scales, legal incapacitation or not giving consent will be excluded.
9 health centers will be randomly assigned to the intervention and control groups. The people of both groups will be evaluated at baseline, at 4 and at 6 months. 57 subjects will be included in each group (n = 114).
Variables: a) Independent: of the professional and of the patients (sociodemographic, healthcare, morbidity, intervention performed -multicomponent vs. non-intervention-) b) Dependents: social support, loneliness and HRQoL.
The intervention includes 8 sessions at home \[1 hour\], every 15 days and 4 telephone \[30 minutes\] -1 monthly-. To measure the effectiveness of the intervention, the Duke-UNC Functional Social Support Questionnaire (DUFSS), the De Jong-Gierveld Scale of loneliness, and the EuroQol-5D will be used to measure HRQoL.
Univariate, bivariate and multivariate statistical analysis (multiple linear regression).
-Aspects ethico-legal: Standards of good clinical practice and ethical principles of the Declaration of Helsinki. Informed consent. Application for authorization to the management of the Sanitary District.
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Detailed Description
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9 health centers will be randomly assigned to the intervention and control groups. The people of both groups will be evaluated at baseline, at 4 and at 6 months. 57 subjects will be included in each group (n = 114).
Variables: a) Independent: of the professional and of the patients (sociodemographic, healthcare, morbidity, intervention performed -multicomponent vs. non-intervention-) b) Dependents: social support, loneliness and HRQoL.
The intervention includes 6 sessions at home \[30-60 minutes\], every 15 days and 5 telephone \[20 minutes\] -1 monthly-. To measure the effectiveness of the intervention, the Duke-UNC Functional Social Support Questionnaire (DUFSS), the De Jong-Gierveld Scale of loneliness, and the EuroQol-5D will be used to measure HRQoL. Analysis by intention to treat. Univariate, bivariate and multivariate statistical analysis (multiple linear regression).
-Aspects ethico-legal: Standards of good clinical practice and ethical principles of the Declaration of Helsinki. Informed consent. Application for authorization to the management of the Sanitary District. Approval of the Ethics and Clinical Research Committee.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention
Non-pharmacological multicomponent intervention
non-pharmacological multicomponent
Following the proposal of Nicholson \& Shellman, (2013) collected in its CARELINK program, an intervention is proposed that includes: 6 sessions at home \[30-60 minutes\] for 16 weeks (1 fortnightly session) and 5 telephone sessions \[20 min.\] That will be intercalated (in the 16 weeks) depending on the particular characteristics of each person. The first visit, aimed at defining objectives and creating a relationship of trust for future visits.
Control
Not intervention, usual attention
No interventions assigned to this group
Interventions
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non-pharmacological multicomponent
Following the proposal of Nicholson \& Shellman, (2013) collected in its CARELINK program, an intervention is proposed that includes: 6 sessions at home \[30-60 minutes\] for 16 weeks (1 fortnightly session) and 5 telephone sessions \[20 min.\] That will be intercalated (in the 16 weeks) depending on the particular characteristics of each person. The first visit, aimed at defining objectives and creating a relationship of trust for future visits.
Eligibility Criteria
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Inclusion Criteria
2. Residents in your home (not institutionalized).
3. Present social isolation: score less than 32 (social support perceived low) with the Duke-UNC Functional Social Support Questionnaire (DUFSS).
Exclusion Criteria
2. Difficulty responding to measurement scales due to language barriers.
3. Legal incapacitation.
4. Do not grant consent for participation in the study.
65 Years
ALL
Yes
Sponsors
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Andaluz Health Service
OTHER_GOV
Responsible Party
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Luis Angel Perula de Torres
Dr. Ph.
Locations
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Luis Angel Perula de Torres
Córdoba, Andalusia, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AP-0079-2016
Identifier Type: -
Identifier Source: org_study_id
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