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Feasibility of Remote Home Support Coaches (SOCIAL Study)

The SOCIAL Study: Feasibility of Remote Home Support Coaches to Decrease the Physical and Psychological Impact of Social Distancing on Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04772820
Enrollment
10
Registered
2021-02-26
Start date
2021-10-15
Completion date
2022-11-30
Last updated
2023-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Isolation, Loneliness, Malnutrition, Sedentary Behavior

Keywords

Covid19, Physical Inactivity, Social Isolation, Inadequate Nutrition, Older Adult, Social Distancing, Remote Home Support, Physical, Psychological, loneliness, behavioral activation

Brief 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.

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.

Interventions

BEHAVIORALTelephone-based 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.

Sponsors

University of Maryland, Baltimore
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* • 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

Exclusion criteria

* • 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

Design outcomes

Primary

MeasureTime frameDescription
Physical Activity - Self-report survey to measure engagement in activitieschange from baseline to 4-month follow-upYale Physical Activity Survey (self-report)
Loneliness assessment - 20 item, self-report assessment to measure lonelinesschange from baseline to 4-month follow-upUCLA 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 walkedchange in steps from the first week of study to final week (week 16) of studyaverage steps walked per day

Secondary

MeasureTime frameDescription
Late Life Function Instrument to access disability in elderlychange from baseline to 4-month follow upLate Life Disability Instrument (LLFDI - self report)
Duke Social Support short scale to measure social support among older peoplechange from baseline to 4-month follow upDuke Social Support Index (self-report)
PROMIS Short form to measure level 2 adult depressionchange from baseline to 4-month follow upPROMIS Depression (Short Form 8-item, self report)
Likert 0-7 rating scale of participants satisfaction with the program4 month follow-upLikert rating of satisfaction
Mini-nutritional assessment to determine if there is risk of malnourishmentchange from baseline to 4-month follow upMini-nutritional assessment - Short Form
PROMIS short-form to measure anxiety in adultschange from baseline to 4-month follow upPROMIS Anxiety (Short form 8-item, self report)
Late Life Function Instrument to assess functionality in elderlychange from baseline to 4-month follow upLate Life Function Instrument (LLFDI - self report)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026