Clinical trial NCT04772820: Feasibility of Remote Home Support Coaches (SOCIAL 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Isolation
Depression
Anxiety
Sedentary Behavior
Loneliness
Keywords: Covid19
Physical Inactivity
Social Isolation
Inadequate Nutrition
Older Adult
Social Distancing
Remote Home Support
Physical
Psychological
loneliness
behavioral activation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: University of Maryland, Baltimore
name: National Institute on Aging (NIA)
First posted: 2021-02-26
Enrollment: 10
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical Activity - Self-report survey to measure engagement in activities
timeFrame: change from baseline to 4-month follow-up
measure: Loneliness assessment - 20 item, self-report assessment to measure loneliness
timeFrame: change from baseline to 4-month follow-up
measure: Physical Activity - step activity monitor to track daily steps walked
timeFrame: change in steps from the first week of study to final week (week 16) of study
Secondary outcomes:
measure: PROMIS Short form to measure level 2 adult depression
timeFrame: change from baseline to 4-month follow up
measure: PROMIS short-form to measure anxiety in adults
timeFrame: change from baseline to 4-month follow up
measure: Late Life Function Instrument to assess functionality in elderly
timeFrame: change from baseline to 4-month follow up
measure: Late Life Function Instrument to access disability in elderly
timeFrame: change from baseline to 4-month follow up
measure: Duke Social Support short scale to measure social support among older people
timeFrame: change from baseline to 4-month follow up
measure: Mini-nutritional assessment to determine if there is risk of malnourishment
timeFrame: change from baseline to 4-month follow up
measure: Likert 0-7 rating scale of participants satisfaction with the program
timeFrame: 4 month follow-up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Shalender Bhasin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Nancy Latham, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, Baltimore
name: Denise Orwig, PhD
role: PRINCIPAL_INVESTIGATOR
References: