Social Isolation, Loneliness (Descriptors Included in the MeSH)ASySNCT03345862
Effectiveness of a Intervention to Reduce the Social Isolation and Loneliness of Elderly Residents at Home
A study testing non-pharmacological multicomponent in people with Social Isolation, Loneliness (Descriptors Included in the MeSH), run by Andaluz Health Service at 1 site in Spain.
Trial 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. 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, Loneliness (Descriptors Included in the MeSH)
- What is being tested?
- non-pharmacological multicomponent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2018to 1 Aug 2020
- 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
- Age 65 years or older.
- Residents in your home (not institutionalized).
- Present social isolation: score less than 32 (social support perceived low) with the Duke-UNC Functional Social Support Questionnaire (DUFSS).
Who cannot join
- Cognitive impairment (Mini-mental <22), or medical diagnosis of dementia.
- Difficulty responding to measurement scales due to language barriers.
- Legal incapacitation.
- Do not grant consent for participation in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Luis Angel Perula de Torres
Córdoba, Andalusia, 14011
Luis Angel Perula de Torres, Dr, 34659681627, luisangel.perula@gmail.com
About this study
Official title: Effectiveness of a Multi-component Non-pharmacological Intervention to Reduce the Social Isolation and Loneliness of Elderly Residents at Home
- 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.
Read more
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.
Read the 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.
- Being tested
- non-pharmacological multicomponent
- Keywords
- Social isolation, Loneliness, Health Related Quality of Life
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-pharmacological multicomponentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Non-pharmacological multicomponent intervention Receives: Behavioral: non-pharmacological multicomponent |
| Control | No intervention | Not intervention, usual attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social isolation
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.
Measured: 6 months
loneliness
De Jong-Gierveld de Soledad Scale, which assesses individual subjective perception of social participation or isolation in the elderly population.
Measured: 6 months
Secondary outcomes (1)
Health Related Quality of Life
Health Related Quality of Life (EuroQol-5D scale)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start15 May 2018
- Primary completion1 Apr 2020
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Isolation, Loneliness (Descriptors Included in the MeSH)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andaluz Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Luis Angel Perula de Torres, Andaluz Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345862
- Sponsor's protocol ID
- AP-0079-2016
- Acronym
- ASyS
- Status last verified
- Jul 2020
- First submitted
- 14 Nov 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multi-component Non-pharmacological Intervention to Reduce the Social Isolation and Loneliness of Elderly Residents at Home
- ClinicalTrials.gov ID
- NCT03345862
- Acronym / sponsor ID
- ASyS / AP-0079-2016
- Keywords
- Social isolation, Loneliness, Health Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Andaluz Health ServiceOther government
- Study start
- 15 May 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 17 Nov 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.
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: non-pharmacological multicomponentNon-pharmacological multicomponent intervention |
| Control | No intervention | –Not intervention, usual attention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65 years or older.
- Residents in your home (not institutionalized).
- Present social isolation: score less than 32 (social support perceived low) with the Duke-UNC Functional Social Support Questionnaire (DUFSS).
Key exclusion criteria (4 listed)
- Cognitive impairment (Mini-mental <22), or medical diagnosis of dementia.
- Difficulty responding to measurement scales due to language barriers.
- Legal incapacitation.
- Do not grant consent for participation in the study.
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 |
|---|---|---|
| non-pharmacological multicomponentFollowing 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. | Behavioural | Intervention |
Primary outcome
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.
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.
1 secondary outcome
Health Related Quality of Life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-pharmacological multicomponent in people with Social Isolation, Loneliness (Descriptors Included in the MeSH), run by Andaluz Health Service at 1 site in Spain.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Angel P de Torres (+34 4659681627, luisangel.perula@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social isolation (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2020.