Social IsolationNCT03142048
Community Intervention to Reduce Social Isolation in Elderly People: a Mixed Methods Multi-approach Evaluation
A study testing Schools of Health for the Elderly in people with Social Isolation and Aging, run by Public Health Agency of Barcelona.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Aging
- What is being tested?
- Schools of Health for the Elderly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2014to 10 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants signing the consent form
Who cannot join
- Participants with difficulties in maintaining participation for 6 months.
- Participants with difficulties in understanding or expressing themselves in Spanish or Catalan.
About this study
Official title: Community Intervention to Reduce Social Isolation in Elderly People in Disadvantaged Urban Areas: Study Protocol for a Mixed Methods Multi-approach Evaluation
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.
Read more
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.
Read the 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
- 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).
- 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.
- 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.
- Conditions
- Social Isolation, Aging
- Being tested
- Schools of Health for the Elderly
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schools of Health for the ElderlyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Schools of Health for the Elderly | Experimental | Participants receiving the community intervention (explained in the section "Intervention") Receives: Other: Schools of Health for the Elderly |
| Comparison Group | No intervention | Participants in the study that do not receive the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Primary care centers have records of all the patient visits.
Measured: The outcome measure will be measured up to 12 months.
Health-related quality of life will be measured through the EuroQoL (EQ-5D)
The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
Measured: 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 National Social Life, Health, and Aging project includes the measurement of social connectedness items
Measured: The outcome measure will be measured up to 12 months.
Social support based on Measures of Quality of Life Core Survey (MOS)
The Medical Outcomes Study Social Support Survey cover four domains (emotional/informational support, tangible [also called instrumental] support, positive social interaction, and affection)
Measured: The outcome measure will be measured up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start10 Dec 2014
- Primary completion10 Sep 2015
- Study completion10 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Agency of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María José López, PhD, Principal investigator, Public Health Agency of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142048
- Sponsor's protocol ID
- ES_2017
- Status last verified
- Apr 2017
- First submitted
- 11 Apr 2017
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36074028Lopez 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.
PubMed 30777022
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Intervention to Reduce Social Isolation in Elderly People in Disadvantaged Urban Areas: Study Protocol for a Mixed Methods Multi-approach Evaluation
- ClinicalTrials.gov ID
- NCT03142048
- Acronym / sponsor ID
- ES_2017
- Conditions
- Social Isolation, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Public Health Agency of BarcelonaUniversity, hospital or other
- Study start
- 10 Dec 2014 (actual)
- Primary completion
- 10 Sep 2015 (actual)
- Study completion
- 10 Dec 2016 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schools of Health for the Elderly | Experimental | Other: Schools of Health for the ElderlyParticipants receiving the community intervention (explained in the section "Intervention") |
| Comparison Group | No intervention | –Participants in the study that do not receive the intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Participants signing the consent form
Key exclusion criteria (2 listed)
- Participants with difficulties in maintaining participation for 6 months.
- Participants with difficulties in understanding or expressing themselves in Spanish or Catalan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schools of Health for the ElderlyThe 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 | Other | Schools of Health for the Elderly |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
Social support based on Measures of Quality of Life Core Survey (MOS)
Time frame: The outcome measure will be measured up to 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Derived from this study: PubMed 36074028Lapena 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.
- Derived from this study: PubMed 30777022Lopez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María José López, PhD principal investigator
Public Health Agency of Barcelona
Questions about this trial
What is this clinical trial studying?
A study testing Schools of Health for the Elderly in people with Social Isolation and Aging, run by Public Health Agency of Barcelona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological morbidity will be measured through Goldberg's General Health Questionnaire (GHQ (time frame: The outcome measure will be measured up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03142048, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017; AzTrials last refreshed its copy on 1 Nov 2026.