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Effectiveness of a Intervention to Reduce the Social Isolation and Loneliness of Elderly Residents at Home (ASyS)

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ClinicalTrials.gov Identifier: NCT03345862
Recruitment Status : Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Luis Angel Perula de Torres, Andaluz Health Service

Brief Summary:
  • Objectives: To evaluate the effectiveness, in terms of reducing social isolation and improving the Health Related Quality of Life (HRQOL), of a non-pharmacological multicomponent intervention in elderly telecare users.
  • Design: Clinical trial randomized by cluster, multicentric.
  • Location: Nine health centers of the Andalusian Health Service (Spain).
  • Subjects and methods: Subjects with social isolation. Age 65 or older. Residents in your home. Telecare users. 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.


Condition or disease Intervention/treatment Phase
Social Isolation, Loneliness (Descriptors Included in the MeSH) Behavioral: non-pharmacological multicomponent Not Applicable

Detailed Description:

-Subjects and methods: Subjects with social isolation. Age 65 or older. Residents in your home. Telecare users. 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. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Multi-component Non-pharmacological Intervention to Reduce the Social Isolation and Loneliness of Elderly Residents at Home
Estimated Study Start Date : January 15, 2018
Estimated Primary Completion Date : March 15, 2018
Estimated Study Completion Date : October 1, 2018

Arm Intervention/treatment
Experimental: Intervention
Non-pharmacological multicomponent intervention
Behavioral: non-pharmacological multicomponent
Following the proposal of Nicholson & Shellman, (2013) collected in its CARELINK program, an intervention is proposed that includes: 8 sessions at home [1h] for 16 weeks (1 fortnightly session) and 4 telephone sessions [30 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.

No Intervention: Control
Not intervention, usual attention



Primary Outcome Measures :
  1. Social isolation [ Time Frame: 6 months ]
    Duke-UNC Functional Social Support Questionnaire (DUFSS), which reflects the opinion on the availability of other people to offer help in difficulties, skills in social relations and empathic and emotional communication.

  2. loneliness [ Time Frame: 6 months ]
    De Jong-Gierveld de Soledad Scale, which assesses individual subjective perception of social participation or isolation in the elderly population.


Secondary Outcome Measures :
  1. Health Related Quality of Life [ Time Frame: 6 months ]
    Health Related Quality of Life (EuroQol-5D scale)



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 65 years or older.
  2. Residents in your home (not institutionalized).
  3. Telecare service users.
  4. Present social isolation: score less than 32 (social support perceived low) with the Duke-UNC Functional Social Support Questionnaire (DUFSS).

Exclusion Criteria:

  1. Cognitive impairment (Mini-mental <22), or medical diagnosis of dementia.
  2. Difficulty responding to measurement scales due to language barriers.
  3. Legal incapacitation.
  4. Do not grant consent for participation in the study.

Responsible Party: Luis Angel Perula de Torres, Dr. Ph., Andaluz Health Service
ClinicalTrials.gov Identifier: NCT03345862     History of Changes
Other Study ID Numbers: AP-0079-2016
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luis Angel Perula de Torres, Andaluz Health Service:
Social isolation, Loneliness, Health Related Quality of Life