Social IsolationNCT04567940
ENRED@TE. Social Support in Southern Spain. Interventional Study
A study testing ENRED@TE: Behavioural multicomponent intervention in people with Social Isolation, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
The main objective to be achieved is to find out if the perceived social support, the perceived loneliness, the perceived social isolation and the family support of those over 65 years of age improve after participating in the Enréd@te project carried out by the Spanish Red Cross (CRE). 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
- What is being tested?
- ENRED@TE: Behavioural multicomponent intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to 1 Jun 2021
- 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
- People over 65 years
- Not institutionalised
Who cannot join
- Participants of other programs
- Difficulty responding to measurement scales due to language barriers
- Legal incapacitation
- People with a residence of less than 3 months in the city
Trial locations and contacts
1 site in 1 country.
Spain1 site
Maimónides Biomedical Research Institute of Córdoba
Córdoba, Cordoba, 14004
About this study
The main objective to be achieved is to find out if the perceived social support, the perceived loneliness, the perceived social isolation and the family support of those over 65 years of age improve after participating in the Enréd@te project carried out by the Spanish Red Cross (CRE).
- Conditions
- Social Isolation
- Being tested
- ENRED@TE: Behavioural multicomponent intervention
- Keywords
- Social isolation, Social support, Loneliness, Family support
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENRED@TE: Behavioural multicomponent interventionBehavioural
Information and awareness activities; activities for the acquisition of skills; activities that help the elderly to attend spaces for leisure, participation and maintenance and/or improvement of their personal relationships.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Behavioural multicomponent intervention Receives: Behavioral: ENRED@TE: Behavioural multicomponent intervention |
| Control group | No intervention | Usual care |
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 (Bellón et al. 1996) is an eight-item instrument to measure the strength of the person's social support network. Each item is ranged from 1 to 5 points, where high scores represent greater social support.
Measured: 6 months
Loneliness
UCLA Loneliness Scale (Russell DW, 1996) which is a 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. This tool use a 4-point rating scale (1= never; 4 = always). High values mean more loneliness.
Measured: 6 months
Secondary outcomes (1)
Detection of risk situations or social problems
Gijón socio-family assessment scale (García González et al. 1999) allows the detection of risk situations or social problems. Values range from 3 to 15. Higher values mean more severe social decline.
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 posted29 Sep 2020
- Study start1 Sep 2019
- Primary completion1 Feb 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567940
- Sponsor's protocol ID
- ENRED@TE
- Status last verified
- Oct 2022
- First submitted
- 23 Sep 2020
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENRED@TE. Social Support in Southern Spain. Interventional Study
- ClinicalTrials.gov ID
- NCT04567940
- Acronym / sponsor ID
- ENRED@TE
- Conditions
- Social Isolation
- Keywords
- Social isolation, Social support, Loneliness, Family support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 29 Sep 2020 (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.
The main objective to be achieved is to find out if the perceived social support, the perceived loneliness, the perceived social isolation and the family support of those over 65 years of age improve after participating in the Enréd@te project carried out by the Spanish Red Cross (CRE).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: ENRED@TE: Behavioural multicomponent interventionBehavioural multicomponent intervention |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- People over 65 years
- Not institutionalised
Key exclusion criteria (4 listed)
- Participants of other programs
- Difficulty responding to measurement scales due to language barriers
- Legal incapacitation
- People with a residence of less than 3 months in the city
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 |
|---|---|---|
| ENRED@TE: Behavioural multicomponent interventionInformation and awareness activities; activities for the acquisition of skills; activities that help the elderly to attend spaces for leisure, participation and maintenance and/or improvement of their personal relationships. | Behavioural | Intervention group |
Primary outcome
Social isolation
Time frame: 6 months
Duke-UNC Functional Social Support Questionnaire (Bellón et al. 1996) is an eight-item instrument to measure the strength of the person's social support network. Each item is ranged from 1 to 5 points, where high scores represent greater social support.
Loneliness
Time frame: 6 months
UCLA Loneliness Scale (Russell DW, 1996) which is a 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. This tool use a 4-point rating scale (1= never; 4 = always). High values mean more loneliness.
1 secondary outcome
Detection of risk situations or social problems
Time frame: 6 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 12 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENRED@TE: Behavioural multicomponent intervention in people with Social Isolation, run by Maimónides Biomedical Research Institute of Córdoba 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 2 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: finished, as of the sponsor's last update on 12 Oct 2022. 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?
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?
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 12 Oct 2022.