MalnutritionNCT04772820
Feasibility of Remote Home Support Coaches (SOCIAL Study)
A study testing Telephone-based coaching in people with Malnutrition and Isolation, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
The goal of this this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of COVID. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Isolation, Depression
- What is being tested?
- Telephone-based coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2021to 30 Nov 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- • Men or women who are 75 years or older
- Must be a patient of Mass General Brigham affiliated with Primary Care Physician departments in Boston, MA OR be a resident of Brightview Senior Living and Assisted Living facilities near Baltimore, MD
Who cannot join
- • Men or women who are 74 years and younger
- Participants who are not affiliated with Primary Care Physician departments at Mass General Brigham or a resident of an assisted living facility in Baltimore, MD
- Unable to adequately complete the Evaluation to Provide Consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: The SOCIAL Study: Feasibility of Remote Home Support Coaches to Decrease the Physical and Psychological Impact of Social Distancing on Older Adults
The goal of this this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of COVID.
Read the detailed description
The goal of this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of COVID.The intervention will focus on decreasing the impact of social isolation, inactivity and poor nutrition on old people during a time when many in-person social activities are not possible. It will be delivered through telephone and other communication tools that allow remote (i.e. not in person) communication over 10 sessions. Subjects will be a total of 60 people aged 75 years an older, who will be recruited from primary care in the Boston MA region and senior living facilities in the Baltimore MD region. Coaches will be trained using an on-line based modules developed to support this intervention. Self-report outcomes will be measured by telephone at baseline and 4-month follow-up.
- Conditions
- Malnutrition, Isolation, Depression, Anxiety, Sedentary Behavior, Loneliness
- Being tested
- Telephone-based coaching
- Keywords
- Covid19, Physical Inactivity, Social Isolation, Inadequate Nutrition, Older Adult, Social Distancing, Remote Home Support, Physical, Psychological, loneliness, behavioral activation
- Medical subject headings
- Malnutrition, Depression, Anxiety Disorders, Sedentary Behavior, COVID-19, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-based coachingBehavioural
Also called Remote coaching
A telephone-based brief behavioral activation coaching program that will involve 10 sessions over 4 months. Sessions will focus on helping people to identify meaningful activities that they can safely do to decrease loneliness, increase physical activity and improve nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Primary Aim | Other | Brief Behavioral Activation coaching will be delivered by telephone and other remote technology by trained coaches. Over 10 sessions, the coaches will help people to find meaningful activities to decrease loneliness, increase physical activity and improve nutrition. Receives: Behavioral: Telephone-based coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity - Self-report survey to measure engagement in activities
Yale Physical Activity Survey (self-report)
Measured: change from baseline to 4-month follow-up
Loneliness assessment - 20 item, self-report assessment to measure loneliness
UCLA Loneliness Scale 3.0 (self-report) 20 item, self-report assessment to measure loneliness. Scale from 1(never) to 4(often)
Measured: change from baseline to 4-month follow-up
Physical Activity - step activity monitor to track daily steps walked
average steps walked per day
Measured: change in steps from the first week of study to final week (week 16) of study
Secondary outcomes (7)
PROMIS Short form to measure level 2 adult depression
PROMIS Depression (Short Form 8-item, self report)
Measured: change from baseline to 4-month follow up
PROMIS short-form to measure anxiety in adults
PROMIS Anxiety (Short form 8-item, self report)
Measured: change from baseline to 4-month follow up
Late Life Function Instrument to assess functionality in elderly
Late Life Function Instrument (LLFDI - self report)
Measured: change from baseline to 4-month follow up
Late Life Function Instrument to access disability in elderly
Late Life Disability Instrument (LLFDI - self report)
Measured: change from baseline to 4-month follow up
Duke Social Support short scale to measure social support among older people
Duke Social Support Index (self-report)
Measured: change from baseline to 4-month follow up
Mini-nutritional assessment to determine if there is risk of malnourishment
Mini-nutritional assessment - Short Form
Measured: change from baseline to 4-month follow up
Likert 0-7 rating scale of participants satisfaction with the program
Likert rating of satisfaction
Measured: 4 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start15 Oct 2021
- Primary completion30 Jun 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This project is a single-group unblinded feasibility study to explore a new telephone-based behavioral activation intervention to support homebound older people. If this intervention appears to be feasible, acceptable, and to show preliminary evidence of efficacy the aim will be to evaluate it in a phase III efficacy trial.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Shalendar Bhasin, MD, Brigham and Women's Hospital
- Investigators
- Shalender Bhasin, MD, Principal investigator, Brigham and Women's HospitalNancy Latham, PhD, Principal investigator, Brigham and Women's HospitalDenise Orwig, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772820
- Sponsor's protocol ID
- 2020P004113
- Other IDs
- 3P30AG031679-10S2
- Status last verified
- Apr 2023
- First submitted
- 23 Feb 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SOCIAL Study: Feasibility of Remote Home Support Coaches to Decrease the Physical and Psychological Impact of Social Distancing on Older Adults
- ClinicalTrials.gov ID
- NCT04772820
- Acronym / sponsor ID
- 2020P004113
- Conditions
- Malnutrition, Isolation, Depression, Anxiety, Sedentary Behavior, Loneliness
- Keywords
- Covid19, Physical Inactivity, Social Isolation, Inadequate Nutrition, Older Adult, Social Distancing, Remote Home Support, Physical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore, National Institute on Aging (NIA)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 26 Feb 2021 (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 goal of this this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of COVID.
Detailed description
The goal of this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of COVID.The intervention will focus on decreasing the impact of social isolation, inactivity and poor nutrition on old people during a time when many in-person social activities are not possible. It will be delivered through telephone and other communication tools that allow remote (i.e. not in person) communication over 10 sessions. Subjects will be a total of 60 people aged 75 years an older, who will be recruited from primary care in the Boston MA region and senior living facilities in the Baltimore MD region. Coaches will be trained using an on-line based modules developed to support this intervention. Self-report outcomes will be measured by telephone at baseline and 4-month follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This project is a single-group unblinded feasibility study to explore a new telephone-based behavioral activation intervention to support homebound older people. If this intervention appears to be feasible, acceptable, and to show preliminary evidence of efficacy the aim will be to evaluate it in a phase III efficacy trial.
| Arm | Type | Receives |
|---|---|---|
| Primary Aim | Other | Behavioral: Telephone-based coachingBrief Behavioral Activation coaching will be delivered by telephone and other remote technology by trained coaches. Over 10 sessions, the coaches will help people to find meaningful activities to decrease loneliness, increase physical activity and improve nutrition. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- • Men or women who are 75 years or older
Key exclusion criteria (3 listed)
- • Men or women who are 74 years and younger
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 |
|---|---|---|
| Telephone-based coachingAlso: Remote coachingA telephone-based brief behavioral activation coaching program that will involve 10 sessions over 4 months. Sessions will focus on helping people to identify meaningful activities that they can safely do to decrease loneliness, increase physical activity and improve nutrition. | Behavioural | Primary Aim |
Primary outcome
Physical Activity - Self-report survey to measure engagement in activities
Time frame: change from baseline to 4-month follow-up
Yale Physical Activity Survey (self-report)
Loneliness assessment - 20 item, self-report assessment to measure loneliness
Time frame: change from baseline to 4-month follow-up
UCLA Loneliness Scale 3.0 (self-report) 20 item, self-report assessment to measure loneliness. Scale from 1(never) to 4(often)
Physical Activity - step activity monitor to track daily steps walked
Time frame: change in steps from the first week of study to final week (week 16) of study
average steps walked per day
7 secondary outcomes
PROMIS Short form to measure level 2 adult depression
Time frame: change from baseline to 4-month follow up
PROMIS short-form to measure anxiety in adults
Time frame: change from baseline to 4-month follow up
Late Life Function Instrument to assess functionality in elderly
Time frame: change from baseline to 4-month follow up
Late Life Function Instrument to access disability in elderly
Time frame: change from baseline to 4-month follow up
Duke Social Support short scale to measure social support among older people
Time frame: change from baseline to 4-month follow up
Mini-nutritional assessment to determine if there is risk of malnourishment
Time frame: change from baseline to 4-month follow up
Likert 0-7 rating scale of participants satisfaction with the program
Time frame: 4 month follow-up
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 25 Apr 2023.
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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.
Shalender Bhasin, MD principal investigator
Brigham and Women's Hospital
Nancy Latham, PhD principal investigator
Brigham and Women's Hospital
Denise Orwig, PhD principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-based coaching in people with Malnutrition and Isolation, run by Brigham and Women's Hospital at 2 sites 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 2 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: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Physical Activity - Self-report survey to measure engagement in activities (time frame: change from baseline to 4-month follow-up). 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 25 Apr 2023.