Clinical trial NCT03142048: Community Intervention to Reduce Social Isolation in Elderly People: a Mixed Methods Multi-approach Evaluation
Official title: Community Intervention to Reduce Social Isolation in Elderly People in Disadvantaged Urban Areas: Study Protocol for a Mixed Methods Multi-approach Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Isolation
Aging
Lead sponsor: Public Health Agency of Barcelona
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 135
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Psychological morbidity will be measured through Goldberg's General Health Questionnaire (GHQ
timeFrame: The outcome measure will be measured up to 12 months.
Secondary outcomes:
measure: Visits to the primary care center will be measured through access to the electronic records of the primary care centers.
timeFrame: The outcome measure will be measured up to 12 months.
measure: Health-related quality of life will be measured through the EuroQoL (EQ-5D)
timeFrame: The outcome measure will be measured up to 12 months.
measure: Social support will be also measured based on the "National Social Life, Health, and Aging Project" questionnaire
timeFrame: The outcome measure will be measured up to 12 months.
measure: Social support based on Measures of Quality of Life Core Survey (MOS)
timeFrame: The outcome measure will be measured up to 12 months.
Other outcomes:
Locations:
Study officials:
affiliation: Public Health Agency of Barcelona
name: María José López, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.