NCT03142048

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
Last Updated

May 5, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

April 11, 2017

Last Update Submit

May 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Psychological morbidity will be measured through Goldberg's General Health Questionnaire (GHQ

    The General Health Questionnaire (GHQ) is a psychometric screening tool to identify common psychiatric conditions.

    The outcome measure will be measured up to 12 months.

Secondary Outcomes (4)

  • Visits to the primary care center will be measured through access to the electronic records of the primary care centers.

    The outcome measure will be measured up to 12 months.

  • Health-related quality of life will be measured through the EuroQoL (EQ-5D)

    The outcome measure will be measured up to 12 months.

  • Social support will be also measured based on the "National Social Life, Health, and Aging Project" questionnaire

    The outcome measure will be measured up to 12 months.

  • Social support based on Measures of Quality of Life Core Survey (MOS)

    The outcome measure will be measured up to 12 months.

Study Arms (2)

Schools of Health for the Elderly

EXPERIMENTAL

Participants receiving the community intervention (explained in the section "Intervention")

Other: Schools of Health for the Elderly

Comparison Group

NO INTERVENTION

Participants in the study that do not receive the intervention

Interventions

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

Schools of Health for the Elderly

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Participants signing the consent form

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Lapena C, Continente X, Sanchez Mascunano A, Mari dell'Olmo M, Lopez MJ. Effectiveness of a community intervention to reduce social isolation among older people in low-income neighbourhoods. Eur J Public Health. 2022 Oct 3;32(5):677-683. doi: 10.1093/eurpub/ckac100.

  • Lopez MJ, Lapena C, Sanchez A, Continente X, Fernandez A; Evaluation Group of the "Schools of Health for older people". Community intervention to reduce social isolation in older adults in disadvantaged urban areas: study protocol for a mixed methods multi-approach evaluation. BMC Geriatr. 2019 Feb 18;19(1):44. doi: 10.1186/s12877-019-1055-9.

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • María José López, PhD

    Public Health Agency of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2017

First Posted

May 5, 2017

Study Start

December 10, 2014

Primary Completion

September 10, 2015

Study Completion

December 10, 2016

Last Updated

May 5, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share