Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03345862
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : July 14, 2020
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: 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.


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 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.

Layout table for study information
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
Actual Study Start Date : May 15, 2018
Actual Primary Completion Date : April 1, 2020
Estimated Study Completion Date : August 1, 2020

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: 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.

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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345862


Contacts
Layout table for location contacts
Contact: Luis Angel P de Torres +34 4659681627 luisangel.perula@gmail.com
Contact: Carlos Perula de Torres +34659681627 carlxz26@gmail.com

Locations
Layout table for location information
Spain
Luis Angel Perula de Torres Recruiting
Córdoba, Andalucía, Spain, 14011
Contact: Luis Angel Perula de Torres, Dr    34659681627    luisangel.perula@gmail.com   
Sponsors and Collaborators
Andaluz Health Service
Layout table for additonal information
Responsible Party: Luis Angel Perula de Torres, Dr. Ph., Andaluz Health Service
ClinicalTrials.gov Identifier: NCT03345862    
Other Study ID Numbers: AP-0079-2016
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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