Social IsolationNCT04131790
Tele-BA for Home-Delivered Meals Clients
A study testing Tele-Behavioral Activation and Tele-Friendly Visiting in people with Social Isolation, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study to evaluate aging-service integrated, video-conference-based approaches to improve homebound seniors' social engagement and activities. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Social Isolation
- What is being tested?
- Tele-Behavioral Activation and Tele-Friendly Visiting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2017to 1 Sep 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Clients of the Meals on Weals program
- ≥60 years old
- Score between 6-9 on the Hughes three-item version of the UCLA Loneliness Scale
Who cannot join
- Dementia, as indicated by a score > 3 on the Six Item Screen
- Clinically significant depression, as indicated by a score ≥15 on the Patient Health Questionnaire (PHQ-9)
- Active suicide risk, as indicated by a positive response on any item of the Columbia Suicide Severity Rating Scale (C-SSRS)
- Uncorrectable hearing or vision impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Social Connectedness in Home Delivered Meals Clients
The purpose of this study to evaluate aging-service integrated, video-conference-based approaches to improve homebound seniors' social engagement and activities.
- Conditions
- Social Isolation
- Being tested
- Tele-Behavioral Activation, Tele-Friendly Visiting
- Keywords
- Loneliness, Homebound, Behavioral Activation
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Behavioral ActivationBehavioural
Five 1-hour sessions of BA delivered by a trained interventionist via video-conferencing
Tele-Friendly VisitingBehavioural
Five 1-hour FV sessions delivered by a trained interventionist via video-conferencing
| Study group | Role | What they receive |
|---|---|---|
| Tele-Behavioral Activation | Experimental | Manualized Behavioral Activation (BA) protocol delivered via videoconferencing by a trained BA interventionist; 5 sessions over 5 weeks, up to 1-hour in length. The interventionist guides participants in learning BA skills, focusing on strategies to decrease barriers to social connectedness (e.g., limited mobility, inadequate caregiving resources). Receives: Behavioral: Tele-Behavioral Activation |
| Tele-Friendly Visiting | Active comparator | Friendly Visitor (FV) calls delivered via videoconferencing by a trained FV interventionist; 5 sessions over 5 weeks, up to 1-hour in length. The interventionist provides social support to participants through good listening and provision of genuine regard. Receives: Behavioral: Tele-Friendly Visiting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time in social support measured using the Duke Social Support Index (DSSI)
A 10-item self-report questionnaire used to measure an individual's satisfaction with social support using a Likert scale (3-point scale, where anchor labels are specified for each item). This scale consists of two subscales: 4-item social interaction (objective support) scale and 6-item satisfaction with social support (subjective support) subscale. Total scores are calculated by summing responses to items across all items; total scores range 10-30.
Measured: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
Change over time in perceived social isolation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Scale
An 8-item self-report questionnaire used to measure perceived social isolation using a Likert scale (5-point scale: 'never' = 1 to 'always' = 5). Total raw scores range from 8-40; raw scores are converted to T-scores using an appendix (T-scores are standardized scores that have a mean of 50 and SD of 10). Higher T-score values represent greater perceived social isolation.
Measured: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
Secondary outcomes (2)
Change over time in depression symptomatology measured using the Patient Health Questionnaire-9 (PHQ-9)
A 9-item self-report questionnaire used to measure symptoms of depression. Items are rated using a Likert scale (4-point scale: 'not at all' = 0 to 'nearly every day' = 3). Total scores are calculated by summing responses to items 1-9; total scores range 0-27.
Measured: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
Change over time in functional disability measured using the World Health Organization Disability Assessment Schedule (WHODAS 2.0)
A 12-item self-report questionnaire used to assess functioning in six domains of life:
Domain 1: Cognition - understanding and communicating Domain 2: Mobility - moving and getting around Domain 3: Self-care - attending to one's hygiene, dressing, eating and staying alone Domain 4: Getting along - interacting with other people Domain 5: Life activities - domestic responsibilities, leisure, work and school Domain 6: Participation - joining in community activities, participating in society.
Items are rated using a Likert scale (5-point scale: 'none' = 0 to 'Extreme/cannot do' = 4). Total scores are calculated by summing responses to items 1-12; total scores range 0-48.
Measured: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start16 Jun 2017
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin
- Responsible party
- Principal investigator, Martha L. Bruce, Dartmouth-Hitchcock Medical Center
- Investigators
- Martha L Bruce, PhD, MPH, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131790
- Sponsor's protocol ID
- D19169
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time there are no plans to share individual patient data.
Publications
Choi NG, Pepin R, Marti CN, Stevens CJ, Bruce ML. Improving Social Connectedness for Homebound Older Adults: Randomized Controlled Trial of Tele-Delivered Behavioral Activation Versus Tele-Delivered Friendly Visits. Am J Geriatr Psychiatry. 2020 Jul;28(7):698-708. doi: 10.1016/j.jagp.2020.02.008. Epub 2020 Mar 2.
PubMed 32238297
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Social Connectedness in Home Delivered Meals Clients
- ClinicalTrials.gov ID
- NCT04131790
- Acronym / sponsor ID
- D19169
- Conditions
- Social Isolation
- Keywords
- Loneliness, Homebound, Behavioral Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- University of Texas at Austin
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 18 Oct 2019 (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 study to evaluate aging-service integrated, video-conference-based approaches to improve homebound seniors' social engagement and activities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-Behavioral Activation | Experimental | Behavioral: Tele-Behavioral ActivationManualized Behavioral Activation (BA) protocol delivered via videoconferencing by a trained BA interventionist; 5 sessions over 5 weeks, up to 1-hour in length. The interventionist guides participants in learning BA skills, focusing on strategies to decrease barriers to social connectedness (e.g., limited mobility, inadequate caregiving resources). |
| Tele-Friendly Visiting | Active comparator | Behavioral: Tele-Friendly VisitingFriendly Visitor (FV) calls delivered via videoconferencing by a trained FV interventionist; 5 sessions over 5 weeks, up to 1-hour in length. The interventionist provides social support to participants through good listening and provision of genuine regard. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- Clients of the Meals on Weals program
- ≥60 years old
- Score between 6-9 on the Hughes three-item version of the UCLA Loneliness Scale
Key exclusion criteria (4 listed)
- Dementia, as indicated by a score > 3 on the Six Item Screen
- Clinically significant depression, as indicated by a score ≥15 on the Patient Health Questionnaire (PHQ-9)
- Active suicide risk, as indicated by a positive response on any item of the Columbia Suicide Severity Rating Scale (C-SSRS)
- Uncorrectable hearing or vision impairment
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 |
|---|---|---|
| Tele-Behavioral ActivationFive 1-hour sessions of BA delivered by a trained interventionist via video-conferencing | Behavioural | Tele-Behavioral Activation |
| Tele-Friendly VisitingFive 1-hour FV sessions delivered by a trained interventionist via video-conferencing | Behavioural | Tele-Friendly Visiting |
Primary outcome
Change over time in social support measured using the Duke Social Support Index (DSSI)
Time frame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
A 10-item self-report questionnaire used to measure an individual's satisfaction with social support using a Likert scale (3-point scale, where anchor labels are specified for each item). This scale consists of two subscales: 4-item social interaction (objective support) scale and 6-item satisfaction with social support (subjective support) subscale. Total scores are calculated by summing responses to items across all items; total scores range 10-30.
Change over time in perceived social isolation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Scale
Time frame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
An 8-item self-report questionnaire used to measure perceived social isolation using a Likert scale (5-point scale: 'never' = 1 to 'always' = 5). Total raw scores range from 8-40; raw scores are converted to T-scores using an appendix (T-scores are standardized scores that have a mean of 50 and SD of 10). Higher T-score values represent greater perceived social isolation.
2 secondary outcomes
Change over time in depression symptomatology measured using the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
Change over time in functional disability measured using the World Health Organization Disability Assessment Schedule (WHODAS 2.0)
Time frame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).
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 8 Oct 2020.
- Derived from this study: PubMed 32238297Choi NG, Pepin R, Marti CN, Stevens CJ, Bruce ML. Improving Social Connectedness for Homebound Older Adults: Randomized Controlled Trial of Tele-Delivered Behavioral Activation Versus Tele-Delivered Friendly Visits. Am J Geriatr Psychiatry. 2020 Jul;28(7):698-708. doi: 10.1016/j.jagp.2020.02.008. Epub 2020 Mar 2.
- Individual participant dataSharing planned: No. At this time there are no plans to share individual patient data.
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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.
Martha L Bruce, PhD, MPH principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Behavioral Activation and Tele-Friendly Visiting in people with Social Isolation, run by Dartmouth-Hitchcock Medical Center 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 4 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 8 Oct 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 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 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?
Change over time in social support measured using the Duke Social Support Index (DSSI) (time frame: Baseline, 6-week follow-up (immediately post-intervention), 12-week follow up (12 weeks post-intervention), 12-month follow-up (12-months post-intervention).). 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?
On the ClinicalTrials.gov record for NCT04131790, which also lists 1 linked publication.
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 8 Oct 2020.