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Community Intervention to Reduce Social Isolation in Elderly People: a Mixed Methods Multi-approach Evaluation

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03142048
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Public Health Agency of Barcelona

Brief Summary:

Background:

The proportion of elderly people has dramatically increased in recent decades. Moreover, social and demographic trends show a global increase of elderly people at risk of loneliness and lack of social relationships. The objective of this study was to evaluate the process, the effectiveness and the cost-effectiveness of an intervention to reduce social isolation and its negative effects on health in elderly persons.

Methods:

This is a mixed methods multi-approach evaluation that includes: 1) A qualitative evaluation among coordinators and participants taking part in the intervention, through in depth-interviews and focus groups, respectively. The main topics covered will be positive and negative aspects of the intervention, suggestions for its improvement, opinions on different aspects of the intervention, and perceived benefits. 2) A quantitative quasi-experimental design, comparing a group of individuals taking part in the intervention with another group with similar characteristics not receiving the intervention. Data will be collected at the beginning and at the end of the intervention. Social support will be measured through questions drawn from the Medical Outcomes Study and the National Social Life, Health, and Aging Project questionnaires. Psychological morbidity will be measured through Goldberg's General Health Questionnaire, and Health-related Quality of Life will be measured through the EuroQoL questionnaire. Information on visits to the primary care center in the years before and after the intervention will be obtained from the electronic records of the primary care centers. 3) A cost-utility analysis, conducted from a health system (primary care) perspective, including direct costs of the program and the primary care health services used. The effects of the intervention will be measured on quality-adjusted life years.

Discussion:

There is an urgent need for studies assessing the effectiveness and the efficiency of potential interventions to reduce social isolation among elderly persons. The results of this study will help to fill the knowledge gap in this area and might be especially useful for the development of social and public health policies and programs for older people in disadvantaged neighborhoods in urban areas.


Condition or disease Intervention/treatment Phase
Social Isolation Aging Other: Schools of Health for the Elderly Not Applicable

Detailed Description:

Hypothesis:

The intervention evaluated in this protocol will significantly improve social support, mental health, general health status and distinct dimensions of quality of life in the intervention group (IG) compared with the comparison group (CG). Among participants in the IG, the intervention will also significantly reduce the number of visits to their primary care centers. Furthermore, this intervention will be cost effective.

Objectives:

General objective To evaluate the process, effectiveness and cost-effectiveness of an intervention to reduce social isolation and its consequent negative impact on health in the elderly.

Specific objectives

  1. To evaluate the implementation process of the intervention (participant profile, positive and negative aspects of the intervention, barriers and facilitators in its implementation, quality of the intervention, and satisfaction).
  2. To assess the impact of the intervention on social support, self-perceived health status, mental health and quality of life among participants, and visits to the primary care center.
  3. To determine the cost-effectiveness of the intervention.

Methods:

Study design

This is a mixed methods multi-approach evaluation that includes:

  • a qualitative evaluation among coordinators and participants who underwent the intervention through in-depth interviews and focus groups, respectively;
  • a quantitative quasi-experimental design, comparing a group of individuals taking part in the intervention (IG) with another group with similar characteristics not receiving the intervention (CG). Data will be collected at the beginning and at the end of the intervention;
  • an economic evaluation, which includes a cost-utility analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Community Intervention to Reduce Social Isolation in Elderly People in Disadvantaged Urban Areas: Study Protocol for a Mixed Methods Multi-approach Evaluation
Actual Study Start Date : December 10, 2014
Actual Primary Completion Date : September 10, 2015
Actual Study Completion Date : December 10, 2016

Arm Intervention/treatment
Experimental: Schools of Health for the Elderly
Participants receiving the community intervention (explained in the section "Intervention")
Other: Schools of Health for the Elderly
The intervention "School of Health for the Elderly " consists of 22 weekly group sessions of 1.5 hours each. In addition to helping participants learn about different health issues, the intervention encourages interaction among participants and works on personal skills. Furthermore, most sessions are led by professionals who are experts on the topic covered and work in the neighborhood (professionals from the health services, social services, markets or neighborhood associations), making it easier to inform participants of the neighborhood's available resources. The aim of the intervention is to decrease social isolation and loneliness and, therefore, to improve mental health, self-perceived health and wellbeing

No Intervention: Comparison Group
Participants in the study that do not receive the intervention



Primary Outcome Measures :
  1. Psychological morbidity will be measured through Goldberg's General Health Questionnaire (GHQ [ Time Frame: The outcome measure will be measured up to 12 months. ]
    The General Health Questionnaire (GHQ) is a psychometric screening tool to identify common psychiatric conditions.


Secondary Outcome Measures :
  1. Visits to the primary care center will be measured through access to the electronic records of the primary care centers. [ Time Frame: The outcome measure will be measured up to 12 months. ]
    Primary care centers have records of all the patient visits.

  2. Health-related quality of life will be measured through the EuroQoL (EQ-5D) [ Time Frame: The outcome measure will be measured up to 12 months. ]
    The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.

  3. Social support will be also measured based on the "National Social Life, Health, and Aging Project" questionnaire [ Time Frame: The outcome measure will be measured up to 12 months. ]
    The National Social Life, Health, and Aging project includes the measurement of social connectedness items

  4. Social support based on Measures of Quality of Life Core Survey (MOS) [ Time Frame: The outcome measure will be measured up to 12 months. ]
    The Medical Outcomes Study Social Support Survey cover four domains (emotional/informational support, tangible [also called instrumental] support, positive social interaction, and affection)



Information from the National Library of Medicine

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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:

  • Participants signing the consent form

Exclusion Criteria:

  • Participants with difficulties in maintaining participation for 6 months.
  • Participants with difficulties in understanding or expressing themselves in Spanish or Catalan.

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): NCT03142048


Sponsors and Collaborators
Public Health Agency of Barcelona
Investigators
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Principal Investigator: María José López, PhD Public Health Agency of Barcelona
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Public Health Agency of Barcelona
ClinicalTrials.gov Identifier: NCT03142048    
Other Study ID Numbers: ES_2017
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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