Social IsolationNCT04593628
Connection for Latinos Caring for a Loved One With Dementia
A study testing Connect for Caregivers in people with Social Isolation and Loneliness, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this research study is to culturally adapt a personalized intervention for Hispanic/Latino caring for a loved one with significant memory problems. The intervention will be designed to help Hispanics/Latinos caring for a loved one with significant memory problems in their own unique context to: 1.)… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Loneliness
- What is being tested?
- Connect for Caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2021to 13 May 2022
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current or previous Hispanic/Latino caregiver (English or Spanish speaking) for a community-dwelling loved one with ADRD, living with (or in close proximity to) loved one with dementia;
- Age 40 or older;
- Able to provide informed consent to participate in the research study.
Who cannot join
- Primary language is not English or Spanish;
- Current alcohol or substance abuse, psychotic disorders (current and lifetime), bipolar disorder and current mood disorders with psychotic features (MINI International Neuropsychiatric Interview);
- Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment (Telephone Interview for Cognitive Status; TICS < 25);
- Hearing problems that preclude completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Adapting 'Connect for Caregivers' for Hispanic Caregivers: A Pilot Study for Year Two of the Rochester Roybal Center for Social Ties and Aging Research (P30AG064103) and the UR Healthy Aging Research Program (HARP)
The purpose of this research study is to culturally adapt a personalized intervention for Hispanic/Latino caring for a loved one with significant memory problems. The intervention will be designed to help Hispanics/Latinos caring for a loved one with significant memory problems in their own unique context to: 1.) understand the importance of social connections for their own health and well-being, 2.) learn to become aware of their own personal barriers to social connections, and 3.) increase their knowledge of local resources for promoting social connections.
- Conditions
- Social Isolation, Loneliness
- Being tested
- Connect for Caregivers
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connect for CaregiversBehavioural
The STAR Center developed Connect for Caregivers to help improve connectedness among older caregivers of individuals with Alzheimer's Disease and Related Dementias (ADRD). Connect for Caregivers includes three components: (1) psychoeducational materials on the importance of connectedness for health and well-being; (2) a card sort-based 'discussion prioritization tool' that systematizes and routinizes the process of identifying and prioritizing barriers to connectedness; (3) personalized resources to address the identified barriers/targets. We will tailor Connect for Caregivers for Hispanic/Latino and Spanish-speaking caregivers guided by the Selective and Directed Treatment Adaptation Framework. The intervention is given once during the study.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | Not described Receives: Behavioral: Connect for Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Basic Psychological Need Satisfaction at Post Intervention
The Basic Psychological Need Satisfaction and Frustration Scales (BPNSFS) will be used. The BPNSFS consists of 24 items assessing both satisfaction and frustration in the need for competence, autonomy, and relatedness, as posited by Self-Determination Theory. We will report changes in the three BPNSFS subscales measuring satisfaction in: autonomy, relatedness and competence. Items are scored on a 1-5 Likert scale with each subscale score ranging from 4-20. Higher scores indicating greater satisfaction. Mean change in subscale scores (change = post intervention scores - baseline scores) will be reported.
Measured: Baseline and 1 hour
Change from Baseline in Basic Psychological Need Frustration at Post Intervention
The Basic Psychological Need Satisfaction and Frustration Scales (BPNSFS) will be used. The BPNSFS consists of 24 items assessing both satisfaction and frustration in the need for competence, autonomy, and relatedness, as posited by Self-Determination Theory. We will report changes in the three BPNSFS subscales measuring frustration in: autonomy, relatedness and competence. Items are scored on a 1-5 Likert scale with each subscale score ranging from 4-20. Higher scores indicating greater frustration. Mean change in subscale scores (change = post intervention scores - baseline scores) will be reported.
Measured: Baseline and 1 hour
Change from Baseline in Ability to Participate in Social Roles and Activities at Post Intervention
The PROMIS Ability to Participate in Social Roles and Activities measure will be used. This scale assesses the perceived ability to perform one's usual social roles and activities. The scale is administered as a computerized adaptive test (CAT) based on a 35 item bank; items are scored on a 1-5 Likert scale. Items are worded negatively in terms of perceived limitations, but responses are reverse-coded. CAT raw scores are converted into T-scores (0-100), with higher scores representing fewer limitations (better abilities). Mean change in T-scores (change = post intervention scores - baseline scores) will be reported.
Measured: Baseline and 1 hour
Secondary outcomes (1)
Change from Baseline in General Self-Efficacy Score at Post Intervention
The PROMIS General Self-Efficacy measure will be used. This scale assesses confidence in one's ability to perform specific tasks or behaviors. The scale is administered as a computerized adaptive test (CAT) based on a 10 item bank; items are scored on a 1-5 Likert scale. CAT raw scores are converted into T-scores (0-100), with higher scores indicating greater self-efficacy. Mean change in T-scores (change = post intervention scores - baseline scores) will be reported.
Measured: Baseline and 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start24 Jan 2021
- Primary completion13 May 2022
- Study completion13 May 2022
Why it stopped: The study aims changed based on the results of a earlier qualitative study.
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.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Caroline Silva, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593628
- Sponsor's protocol ID
- STUDY00005437
- Other IDs
- P30AG064103
- Status last verified
- Sep 2022
- First submitted
- 14 Oct 2020
- Last updated
- 10 Sep 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 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting 'Connect for Caregivers' for Hispanic Caregivers: A Pilot Study for Year Two of the Rochester Roybal Center for Social Ties and Aging Research (P30AG064103) and the UR Healthy Aging Research Program (HARP)
- ClinicalTrials.gov ID
- NCT04593628
- Acronym / sponsor ID
- STUDY00005437
- Conditions
- Social Isolation, Loneliness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study aims changed based on the results of a earlier qualitative study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 24 Jan 2021 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 20 Oct 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 purpose of this research study is to culturally adapt a personalized intervention for Hispanic/Latino caring for a loved one with significant memory problems. The intervention will be designed to help Hispanics/Latinos caring for a loved one with significant memory problems in their own unique context to: 1.) understand the importance of social connections for their own health and well-being, 2.) learn to become aware of their own personal barriers to social connections, and 3.) increase their knowledge of local resources for promoting social connections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Behavioral: Connect for Caregivers |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current or previous Hispanic/Latino caregiver (English or Spanish speaking) for a community-dwelling loved one with ADRD, living with (or in close proximity to) loved one with dementia;
- Age 40 or older;
- Able to provide informed consent to participate in the research study.
Key exclusion criteria (4 listed)
- Primary language is not English or Spanish;
- Current alcohol or substance abuse, psychotic disorders (current and lifetime), bipolar disorder and current mood disorders with psychotic features (MINI International Neuropsychiatric Interview);
- Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment (Telephone Interview for Cognitive Status; TICS < 25);
- Hearing problems that preclude completion of 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 |
|---|---|---|
| Connect for CaregiversThe STAR Center developed Connect for Caregivers to help improve connectedness among older caregivers of individuals with Alzheimer's Disease and Related Dementias (ADRD). Connect for Caregivers includes three components: (1) psychoeducational materials on the importance of connectedness for health and well-being; (2) a card sort-based 'discussion prioritization tool' that systematizes and routinizes the process of identifying and prioritizing barriers to connectedness; (3) personalized resources to address the identified barriers/targets. We will tailor Connect for Caregivers for Hispanic/Latino and Spanish-speaking caregivers guided by the Selective and Directed Treatment Adaptation Framework. The intervention is given once during the study. | Behavioural | All Participants |
Primary outcome
Change from Baseline in Basic Psychological Need Satisfaction at Post Intervention
Time frame: Baseline and 1 hour
The Basic Psychological Need Satisfaction and Frustration Scales (BPNSFS) will be used. The BPNSFS consists of 24 items assessing both satisfaction and frustration in the need for competence, autonomy, and relatedness, as posited by Self-Determination Theory. We will report changes in the three BPNSFS subscales measuring satisfaction in: autonomy, relatedness and competence. Items are scored on a 1-5 Likert scale with each subscale score ranging from 4-20. Higher scores indicating greater satisfaction. Mean change in subscale scores (change = post intervention scores - baseline scores) will be reported.
Change from Baseline in Basic Psychological Need Frustration at Post Intervention
Time frame: Baseline and 1 hour
The Basic Psychological Need Satisfaction and Frustration Scales (BPNSFS) will be used. The BPNSFS consists of 24 items assessing both satisfaction and frustration in the need for competence, autonomy, and relatedness, as posited by Self-Determination Theory. We will report changes in the three BPNSFS subscales measuring frustration in: autonomy, relatedness and competence. Items are scored on a 1-5 Likert scale with each subscale score ranging from 4-20. Higher scores indicating greater frustration. Mean change in subscale scores (change = post intervention scores - baseline scores) will be reported.
Change from Baseline in Ability to Participate in Social Roles and Activities at Post Intervention
Time frame: Baseline and 1 hour
The PROMIS Ability to Participate in Social Roles and Activities measure will be used. This scale assesses the perceived ability to perform one's usual social roles and activities. The scale is administered as a computerized adaptive test (CAT) based on a 35 item bank; items are scored on a 1-5 Likert scale. Items are worded negatively in terms of perceived limitations, but responses are reverse-coded. CAT raw scores are converted into T-scores (0-100), with higher scores representing fewer limitations (better abilities). Mean change in T-scores (change = post intervention scores - baseline scores) will be reported.
1 secondary outcome
Change from Baseline in General Self-Efficacy Score at Post Intervention
Time frame: Baseline and 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 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 Connect for Caregivers in people with Social Isolation and Loneliness, run by University of Rochester at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 10 Sep 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change from Baseline in Basic Psychological Need Satisfaction at Post Intervention (time frame: Baseline and 1 hour). 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?
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 10 Sep 2022.