Social IsolationNCT05520450
Telematic Support Group in Patients With Feelings of Loneliness and Social Isolation
An observational study of Social Isolation and Loneliness, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Loneliness can have negative consequences, both physically and psychologically. The aim of this study is to evaluate the effects of a telematic group intervention in reducing feelings of loneliness and social isolation, as well as improving the emotional well-being of people in home care. Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Social Isolation, Loneliness
- What is being tested?
- Telematic support group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to Mar 2023
- Phase
- Observational
- 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 60 to 99 years
- All sexes
- Adult, Older adult
Study population: Patients with chronic, degenerative and/or incapacitating pathologies or with unfavourable biopsychosocial characteristics; social isolation, advanced age, autonomy deficits or architectural barriers. Patients aged 60 to 99 years resident in the Sabadell 4B health area who receive regular home care in the ATDOM Programme by the Primary Care Team of the Corporació Sanitària Parc Taulí, who agree to participate in the study and meet the eligibility criteria.
Who may be able to join
- Men or women aged 60-99 years.
- Voluntary signature of informed consent.
- Presence of feelings of loneliness and social isolation, self-reported or detected through information from third parties.
- Mobile device with internet connection and basic skills to operate it.
- Literacy: knowing how to read and write.
- People with low psychopathological complexity. The definition is established in patients with mental disorders of low complexity, at a syndromic level related to anxiety and depression. In the absence of difficulties in management, torpid evolution or clarifying clinical need.
- Motivation, attitude and ability to work in a group.
- Receptive attitude to learning new skills and sharing experiences.
Who cannot join
- People in temporary home care for less than one month (traumatisms, surgery, hospital discharges with a moderate degree of dependency, rehabilitation treatments or therapies).
- Presence of legal incapacitation, not related to a physical level. People with an inability to make decisions due to their mental or intellectual incapacity.
- Comorbidity with disorders incompatible with treatment: moderate or severe cognitive impairment, alterations in verbal communication, severe vision loss or hearing loss.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Parc Taulí
Sabadell, Barcelona, 08208
Coloma Moreno Quiroga, PhD, 93 723 66 73, CMoreno@tauli.cat
About this study
Official title: Telematic Support Group in the Care of Domiciliary Patients With Feelings of Loneliness and Social Isolation: a Social Study
Loneliness can have negative consequences, both physically and psychologically. The aim of this study is to evaluate the effects of a telematic group intervention in reducing feelings of loneliness and social isolation, as well as improving the emotional well-being of people in home care. The sample is made up of patients aged 60 to 99 years resident in Sabadell health area who receive regular home care in the ATDOM Programme by the Primary Care Team of the Corporació Sanitària Parc Taulí, who agree to participate in the study and meet the eligibility criteria. The study includes clinical assessments, emotional well-being, social support and satisfaction with the intervention.
Read the detailed description
Loss of autonomy, cognitive impairment and fragility of health can lead to a complex social situation and isolation. Loneliness has been defined as the aversive state that accompanies the perception of a deficit in the quality or quantity of social relationships. It is relevant to conceive loneliness as a complex, diverse and plural phenomenon that requires tools for its detection, understanding and accompaniment during the intervention process. The importance of acting on unwanted loneliness is reflected in the consequences for physical and psychological health. In the long term, chronic and unwanted subjective loneliness leads to consequences such as poorer objective and subjective physical health, increased morbidity and mortality, a risk factor for the development of cognitive impairment, as well as an association with lower self-esteem and sense of identity. The present research study aims to investigate the feasibility of a telematic group intervention in reducing feelings of loneliness and social isolation, as well as improving the emotional well-being of people in home care. A pilot clinical trial with a pre-post intrasubject design will be carried out. The sample is made up of patients aged 60 to 99 years resident in the Sabadell 4B health area who receive regular home care in the ATDOM Programme by the Primary Care Team of the Corporació Sanitària Parc Taulí, who agree to participate in the study and meet the eligibility criteria. The intervention is developed through participation in a telematic support group of 7 sessions of 90 minutes distributed over 2 months, establishing a pre-post intervention evaluation. The study includes clinical assessments, emotional well-being, social support and satisfaction with the intervention. Quantitative variables will be analysed using the non-parametric Wilcoxon signed-rank test. For a more precise interpretation of the relevance of the results in each domain assessed, effect sizes will be calculated for pre-post changes, using Cohen's d. A qualitative analysis of satisfaction with the intervention will also be carried out.
- Conditions
- Social Isolation, Loneliness
- Being tested
- Telematic support group
- Keywords
- Social Isolation, Loneliness, Domiciliary patients, Support group, Telematic
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telematic support groupBehavioural
The participation of each patient in the study has been established for 4 months; the first and last months correspond to the evaluation phase, the remaining two months are for the intervention. A total of 7 group sessions of 90 minutes duration and weekly frequency are scheduled, carried out via telematics and conducted by an emotional well-being professional, a nurse and a social worker. In this context, it is guaranteed that patients will receive the care, visits and treatments usually used for people who have presented their clinical situation. The only difference between participating in the intervention and not participating in the intervention is the participation in a telematic support group and some additional assessments, i.e. not routinely carried out, which are part of this project. The intervention will be carried out in a group format, with a maximum of 12 patients per session.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Recruitment will be based on consecutive patients receiving regular home care in the ATDOM Programme by the Primary Care Team, with prior informed consent. Receives: Behavioral: Telematic support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline for loneliness compared to post-intervention
UCLA Loneliness Scale version 3. It will be used to quantify the level of subjective loneliness. It consists of 20 items, which are answered on a 4-point Likert scale (1 = "never" and 4 = "always"). There are no cut-off points; higher scores indicate greater severity of loneliness.
Measured: In total, 2 assessments will be carried out. The assessments will take place before and after the intervention, at 4 months. The assessments will last 30 minutes.
Change in baseline for social isolation compared to post-intervention
OSLO 3 Scale. It will be used to measure perceived social support. It consists of 3 items. Scores between 3 and 8 show poor social support; between 9 and 11 medium social support; between 12 and 15 high social support.
Measured: In total, 2 assessments will be carried out. The assessments will take place before and after the intervention, at 4 months. The assessments will last 30 minutes.
Change in baseline for anxiety and depression compared to post-intervention
Goldberg Anxiety and Depression Scale (EADG). It will be used to quantify the severity of anxiety and depression symptoms. It consists of 18 items measured with dichotomous responses. It contains two subscales, with 9 questions each: anxiety subscale and depression subscale. The first 4 questions of each subscale (questions 1-4) and (questions 10-13) respectively, act as a precondition to determine whether the rest of the questions should be answered. The cut-off points are 4 or more for the anxiety subscale and 2 or more for the depression subscale. Higher scores indicate greater severity of symptoms.
Measured: In total, 2 assessments will be carried out. The assessments will take place before and after the intervention, at 4 months. The assessments will last 30 minutes.
Secondary outcomes (2)
Change in baseline for feasibility of the intervention compared to post-intervention
Debriefing session with the research team at the end of the intervention. These will be used for qualitative assessment of the feasibility of the intervention: measured by the total number of attendances and absences of the participants in each session.
Measured: The assessments will take place after the intervention, at 4 months. The assessments will last 30 minutes.
Change in baseline for satisfaction of the intervention compared to post-intervention
Debriefing session with the research team at the end of the intervention. These will be used for qualitative assessment of the satisfaction of the intervention: satisfaction with the intervention by the professionals and patients.
Measured: The assessments will take place after the intervention, at 4 months. The assessments will last 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Sep 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Comendador-Vazquez, Corporacion Parc Tauli
- Investigators
- Laura Comendador Vazquez, master, Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520450
- Sponsor's protocol ID
- 2022/3009
- Status last verified
- Feb 2023
- First submitted
- 12 Jul 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no a plan to make individual participant data (IPD) available to other researchers.
Publications
Sander R. Preventing social isolation and loneliness among older people: a systematic review of health promotion interventions. Nurs Older People. 2005 Mar 1;17(1):40. doi: 10.7748/nop.17.1.40.s11.
PubMed 27736564Cohen-Mansfield J, Hazan H, Lerman Y, Shalom V. Correlates and predictors of loneliness in older-adults: a review of quantitative results informed by qualitative insights. Int Psychogeriatr. 2016 Apr;28(4):557-76. doi: 10.1017/S1041610215001532. Epub 2015 Oct 1.
PubMed 26424033Bermeja AI, Ausin B. [Programs to combat loneliness in the institutionalised elderly: A review of the scientific literature]. Rev Esp Geriatr Gerontol. 2018 May-Jun;53(3):155-164. doi: 10.1016/j.regg.2017.05.006. Epub 2017 Nov 1. Spanish.
PubMed 29100718Courtin E, Knapp M. Social isolation, loneliness and health in old age: a scoping review. Health Soc Care Community. 2017 May;25(3):799-812. doi: 10.1111/hsc.12311. Epub 2015 Dec 28.
PubMed 26712585Domenech-Abella J, Lara E, Rubio-Valera M, Olaya B, Moneta MV, Rico-Uribe LA, Ayuso-Mateos JL, Mundo J, Haro JM. Loneliness and depression in the elderly: the role of social network. Soc Psychiatry Psychiatr Epidemiol. 2017 Apr;52(4):381-390. doi: 10.1007/s00127-017-1339-3. Epub 2017 Feb 2.
PubMed 28154893Masi CM, Chen HY, Hawkley LC, Cacioppo JT. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66. doi: 10.1177/1088868310377394. Epub 2010 Aug 17.
PubMed 20716644Morris SB, DeShon RP. Combining effect size estimates in meta-analysis with repeated measures and independent-groups designs. Psychol Methods. 2002 Mar;7(1):105-25. doi: 10.1037/1082-989x.7.1.105.
PubMed 11928886Syed Elias SM, Neville C, Scott T. The effectiveness of group reminiscence therapy for loneliness, anxiety and depression in older adults in long-term care: a systematic review. Geriatr Nurs. 2015 Sep-Oct;36(5):372-80. doi: 10.1016/j.gerinurse.2015.05.004. Epub 2015 Jun 19.
PubMed 26099638
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telematic Support Group in the Care of Domiciliary Patients With Feelings of Loneliness and Social Isolation: a Social Study
- ClinicalTrials.gov ID
- NCT05520450
- Acronym / sponsor ID
- 2022/3009
- Conditions
- Social Isolation, Loneliness
- Keywords
- Social Isolation, Loneliness, Domiciliary patients, Support group, Telematic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 30 Aug 2022 (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.
Loneliness can have negative consequences, both physically and psychologically. The aim of this study is to evaluate the effects of a telematic group intervention in reducing feelings of loneliness and social isolation, as well as improving the emotional well-being of people in home care. The sample is made up of patients aged 60 to 99 years resident in Sabadell health area who receive regular home care in the ATDOM Programme by the Primary Care Team of the Corporació Sanitària Parc Taulí, who agree to participate in the study and meet the eligibility criteria. The study includes clinical assessments, emotional well-being, social support and satisfaction with the intervention.
Detailed description
Loss of autonomy, cognitive impairment and fragility of health can lead to a complex social situation and isolation. Loneliness has been defined as the aversive state that accompanies the perception of a deficit in the quality or quantity of social relationships. It is relevant to conceive loneliness as a complex, diverse and plural phenomenon that requires tools for its detection, understanding and accompaniment during the intervention process. The importance of acting on unwanted loneliness is reflected in the consequences for physical and psychological health. In the long term, chronic and unwanted subjective loneliness leads to consequences such as poorer objective and subjective physical health, increased morbidity and mortality, a risk factor for the development of cognitive impairment, as well as an association with lower self-esteem and sense of identity. The present research study aims to investigate the feasibility of a telematic group intervention in reducing feelings of loneliness and social isolation, as well as improving the emotional well-being of people in home care. A pilot clinical trial with a pre-post intrasubject design will be carried out. The sample is made up of patients aged 60 to 99 years resident in the Sabadell 4B health area who receive regular home care in the ATDOM Programme by the Primary Care Team of the Corporació Sanitària Parc Taulí, who agree to participate in the study and meet the eligibility criteria. The intervention is developed through participation in a telematic support group of 7 sessions of 90 minutes distributed over 2 months, establishing a pre-post intervention evaluation. The study includes clinical assessments, emotional well-being, social support and satisfaction with the intervention. Quantitative variables will be analysed using the non-parametric Wilcoxon signed-rank test. For a more precise interpretation of the relevance of the results in each domain assessed, effect sizes will be calculated for pre-post changes, using Cohen's d. A qualitative analysis of satisfaction with the intervention will also be carried out.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Behavioral: Telematic support groupRecruitment will be based on consecutive patients receiving regular home care in the ATDOM Programme by the Primary Care Team, with prior informed consent. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic, degenerative and/or incapacitating pathologies or with unfavourable biopsychosocial characteristics; social isolation, advanced age, autonomy deficits or architectural barriers. Patients aged 60 to 99 years resident in the Sabadell 4B health area who receive regular home care in the ATDOM Programme by the Primary Care Team of the Corporació Sanitària Parc Taulí, who agree to participate in the study and meet the eligibility criteria.
Key inclusion criteria (8 listed)
- Men or women aged 60-99 years.
- Voluntary signature of informed consent.
- Presence of feelings of loneliness and social isolation, self-reported or detected through information from third parties.
- Mobile device with internet connection and basic skills to operate it.
- Literacy: knowing how to read and write.
Key exclusion criteria (3 listed)
- People in temporary home care for less than one month (traumatisms, surgery, hospital discharges with a moderate degree of dependency, rehabilitation treatments or therapies).
- Presence of legal incapacitation, not related to a physical level. People with an inability to make decisions due to their mental or intellectual incapacity.
- Comorbidity with disorders incompatible with treatment: moderate or severe cognitive impairment, alterations in verbal communication, severe vision loss or hearing loss.
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 |
|---|---|---|
| Telematic support groupThe participation of each patient in the study has been established for 4 months; the first and last months correspond to the evaluation phase, the remaining two months are for the intervention. A total of 7 group sessions of 90 minutes duration and weekly frequency are scheduled, carried out via telematics and conducted by an emotional well-being professional, a nurse and a social worker. In this context, it is guaranteed that patients will receive the care, visits and treatments usually used for people who have presented their clinical situation. The only difference between participating in the intervention and not participating in the intervention is the participation in a telematic support group and some additional assessments, i.e. not routinely carried out, which are part of this project. The intervention will be carried out in a group format, with a maximum of 12 patients per session. | Behavioural | Intervention group |
Primary outcome
Change in baseline for loneliness compared to post-intervention
Time frame: In total, 2 assessments will be carried out. The assessments will take place before and after the intervention, at 4 months. The assessments will last 30 minutes.
UCLA Loneliness Scale version 3. It will be used to quantify the level of subjective loneliness. It consists of 20 items, which are answered on a 4-point Likert scale (1 = "never" and 4 = "always"). There are no cut-off points; higher scores indicate greater severity of loneliness.
Change in baseline for social isolation compared to post-intervention
Time frame: In total, 2 assessments will be carried out. The assessments will take place before and after the intervention, at 4 months. The assessments will last 30 minutes.
OSLO 3 Scale. It will be used to measure perceived social support. It consists of 3 items. Scores between 3 and 8 show poor social support; between 9 and 11 medium social support; between 12 and 15 high social support.
Change in baseline for anxiety and depression compared to post-intervention
Time frame: In total, 2 assessments will be carried out. The assessments will take place before and after the intervention, at 4 months. The assessments will last 30 minutes.
Goldberg Anxiety and Depression Scale (EADG). It will be used to quantify the severity of anxiety and depression symptoms. It consists of 18 items measured with dichotomous responses. It contains two subscales, with 9 questions each: anxiety subscale and depression subscale. The first 4 questions of each subscale (questions 1-4) and (questions 10-13) respectively, act as a precondition to determine whether the rest of the questions should be answered. The cut-off points are 4 or more for the anxiety subscale and 2 or more for the depression subscale. Higher scores indicate greater severity of symptoms.
2 secondary outcomes
Change in baseline for feasibility of the intervention compared to post-intervention
Time frame: The assessments will take place after the intervention, at 4 months. The assessments will last 30 minutes.
Change in baseline for satisfaction of the intervention compared to post-intervention
Time frame: The assessments will take place after the intervention, at 4 months. The assessments will last 30 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Background: PubMed 27736564Sander R. Preventing social isolation and loneliness among older people: a systematic review of health promotion interventions. Nurs Older People. 2005 Mar 1;17(1):40. doi: 10.7748/nop.17.1.40.s11.
- Background: PubMed 26424033Cohen-Mansfield J, Hazan H, Lerman Y, Shalom V. Correlates and predictors of loneliness in older-adults: a review of quantitative results informed by qualitative insights. Int Psychogeriatr. 2016 Apr;28(4):557-76. doi: 10.1017/S1041610215001532. Epub 2015 Oct 1.
- Background: PubMed 29100718Bermeja AI, Ausin B. [Programs to combat loneliness in the institutionalised elderly: A review of the scientific literature]. Rev Esp Geriatr Gerontol. 2018 May-Jun;53(3):155-164. doi: 10.1016/j.regg.2017.05.006. Epub 2017 Nov 1. Spanish.
- Background: PubMed 26712585Courtin E, Knapp M. Social isolation, loneliness and health in old age: a scoping review. Health Soc Care Community. 2017 May;25(3):799-812. doi: 10.1111/hsc.12311. Epub 2015 Dec 28.
- Background: PubMed 28154893Domenech-Abella J, Lara E, Rubio-Valera M, Olaya B, Moneta MV, Rico-Uribe LA, Ayuso-Mateos JL, Mundo J, Haro JM. Loneliness and depression in the elderly: the role of social network. Soc Psychiatry Psychiatr Epidemiol. 2017 Apr;52(4):381-390. doi: 10.1007/s00127-017-1339-3. Epub 2017 Feb 2.
- Background: PubMed 20716644Masi CM, Chen HY, Hawkley LC, Cacioppo JT. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66. doi: 10.1177/1088868310377394. Epub 2010 Aug 17.
- Background: PubMed 11928886Morris SB, DeShon RP. Combining effect size estimates in meta-analysis with repeated measures and independent-groups designs. Psychol Methods. 2002 Mar;7(1):105-25. doi: 10.1037/1082-989x.7.1.105.
- Background: PubMed 26099638Syed Elias SM, Neville C, Scott T. The effectiveness of group reminiscence therapy for loneliness, anxiety and depression in older adults in long-term care: a systematic review. Geriatr Nurs. 2015 Sep-Oct;36(5):372-80. doi: 10.1016/j.gerinurse.2015.05.004. Epub 2015 Jun 19.
- Individual participant dataSharing planned: No. There is no a plan to make individual participant data (IPD) available to other researchers.
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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.
Laura Comendador Vazquez, master principal investigator
Corporacion Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Social Isolation and Loneliness, run by Corporacion Parc Tauli 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 8 inclusion and 3 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 9 Feb 2023. 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 Laura Comendador Vazquez, master (622054658, lcomendador@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline for loneliness compared to post-intervention (time frame: In total, 2 assessments will be carried out. The assessments will take place before and after the intervention, at 4 months. The assessments will last 30 minutes.). The study lists 3 primary outcomes in all. 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 NCT05520450, which also lists 8 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 9 Feb 2023.