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AGE SELF CARE: Promoting Healthy Aging Through a Group Visit Program

Primary Purpose

Frailty, Aging, Frailty Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AGE SELF CARE group visit program
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty focused on measuring yoga, mind-body, pre-frail, healthy aging

Eligibility Criteria

65 Years - 110 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Community-dwelling adults age 65+. Pre-frail (1-2 points on FRAIL scale) during pre-screening. Agree to participate and commit to all study procedures. Able to speak English. Access to and ability to use a smartphone, tablet, or computer and broadband internet. Exclusion criteria: Younger than age 65. Robust (0 points) or frail (3+ points) on FRAIL scale during phone screening. Established diagnosis of dementia. Untreated psychiatric symptoms affecting group participation. Hearing or visual impairment affecting participation in a virtual program.

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AGE SELF CARE group visit program

Arm Description

Participants will take part in 8 weekly 90-minute virtual group visit program sessions

Outcomes

Primary Outcome Measures

Recruitment rate
Proportion of contacted potential participants who enrolled in the study
Completion of testing
Proportion of enrolled participants who completed testing for the study; time taken to complete testing
Attendance
Proportion of participants who attend at least 6 of 8 scheduled Zoom visits
Completion of home practice log
Proportion of of participants who complete the home practice log each week
Participant satisfaction
Participant satisfaction with program, visual analog scale from 1 to 10 (10 indicating highest satisfaction)
Proportion lost to follow-up
Proportion of enrolled participants who were lost to follow-up (unable to be contacted during study)

Secondary Outcome Measures

Frailty index
Measurement of a frailty index based on the deficit accumulation model (PMID: 32072368)
Loneliness
University of California at Los Angeles 3-item Loneliness Questionnaire
Self-reported health
General health perception (from SF-12)
Godin Leisure-Time Exercise Questionnaire
Physical activity
Self-efficacy
1 question from New General Self-Efficacy Scale
Patient health questionnaire 2-item scale (PHQ-2)
Depression
Generalized Anxiety Disorder 2-item scale (GAD-2)
Anxiety
Sleep
Sleep questions from Patient Reported Outcome Measurement Information System (PROMIS-29) questionnaire
Short Physical Performance Battery (SPPB)
Measures of balance, gait speed, and chair stands

Full Information

First Posted
September 29, 2023
Last Updated
October 6, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06079762
Brief Title
AGE SELF CARE: Promoting Healthy Aging Through a Group Visit Program
Official Title
AGE SELF CARE: Promoting Healthy Aging Through a Group Visit Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim 1: To assess the feasibility and acceptability of delivering AGE SELF CARE through virtual medical group visits by measuring recruitment rate, adherence, and participant satisfaction. Hypothesis 1: It will be feasible to recruit 12 older adults who are pre-frail. Hypothesis 2: At least 70% of participants will attend 6 of 8 group visit sessions. Hypothesis 3: At least 70% of participants will report satisfaction with the program. Aim 2: Determine the feasibility and burden of measuring frailty in this study by different instruments. Hypothesis 1: At least 70% of participants will complete portions of all frailty assessments. Hypothesis 2: Participants will not find testing to be burdensome and measures may be completed in 60 minutes or less. Hypothesis 3: Mean gait speed and frailty index will improve from baseline to post-intervention.
Detailed Description
Study Design: pilot study Setting: BWH Osher Clinical Center for Integrative Medicine, or "OCC", is a collaboration between BWH and Harvard Medical School (HMS), focused on enhancing human health, resilience, and quality of life through translational research, clinical practice, and education in integrative medicine. The OCC is comprised of an interdisciplinary team of physicians, chiropractors, acupuncturists, massage therapists, coaches, nutritionists, craniosacral therapists, and other practitioners who treat patients with a variety of conditions. Patients across New England regularly access the OCC through self-referral or referral from primary care or subspecialty practices. Participants: Community-dwelling adults aged 65 years and older who are pre-frail (based on FRAIL) during the initial study visit (n=12). Intervention: AGE SELF CARE consists of 8 weekly 90-minute virtual group visits, with approximately 12 participants in each group. Sessions focus on chronic disease management; healthy lifestyle education, including nutrition, physical activity, sleep, stress management, and socialization; home adaptation to optimize the home environment for usability and safety with aging; and anticipatory guidance. Educational materials include a library of handouts and pre-recorded videos from interdisciplinary team members about a topic. The group applies learning to their own lives, develops personal goals, and reports back about brief home activities or practices. Sessions will be modified and targeted toward frailty prevention according to existing data and published guidelines. For example, the Mediterranean diet will be discussed as a nutritional approach that can reduce frailty progression. Physical activity guidelines will focus on resistance training to simulate daily activities, power training, balance exercise, and mind-body movement. Finally, sessions will include information on home safety modification and polypharmacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Aging, Frailty Syndrome, Frail Elderly Syndrome
Keywords
yoga, mind-body, pre-frail, healthy aging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-group feasibility/acceptability, stage I (NIH stage model for behavioral intervention development)
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AGE SELF CARE group visit program
Arm Type
Experimental
Arm Description
Participants will take part in 8 weekly 90-minute virtual group visit program sessions
Intervention Type
Behavioral
Intervention Name(s)
AGE SELF CARE group visit program
Intervention Description
AGE SELF CARE: "Adaptation, Growth, and Engagement; Socialization, Empowerment, Learning, and Function; and Community Activation for Resilience in Elderhood," is a virtual group visit program. It includes education and behavioral change elements in the broad areas of self/health, home environment, and community. There are 8 weekly 90-minute virtual sessions facilitated by an aging expert (e.g., geriatrician). Examples of topics include "Aging Well: The Power of Movement," "People Can Change, Homes Can Too," and "Social World."
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Proportion of contacted potential participants who enrolled in the study
Time Frame
Baseline
Title
Completion of testing
Description
Proportion of enrolled participants who completed testing for the study; time taken to complete testing
Time Frame
Baseline and immediately after the intervention
Title
Attendance
Description
Proportion of participants who attend at least 6 of 8 scheduled Zoom visits
Time Frame
Immediately after the intervention
Title
Completion of home practice log
Description
Proportion of of participants who complete the home practice log each week
Time Frame
Immediately after the intervention
Title
Participant satisfaction
Description
Participant satisfaction with program, visual analog scale from 1 to 10 (10 indicating highest satisfaction)
Time Frame
Immediately after the intervention
Title
Proportion lost to follow-up
Description
Proportion of enrolled participants who were lost to follow-up (unable to be contacted during study)
Time Frame
Immediately after the intervention
Secondary Outcome Measure Information:
Title
Frailty index
Description
Measurement of a frailty index based on the deficit accumulation model (PMID: 32072368)
Time Frame
Baseline and immediately after the intervention
Title
Loneliness
Description
University of California at Los Angeles 3-item Loneliness Questionnaire
Time Frame
Baseline and immediately after the intervention
Title
Self-reported health
Description
General health perception (from SF-12)
Time Frame
Baseline and immediately after the intervention
Title
Godin Leisure-Time Exercise Questionnaire
Description
Physical activity
Time Frame
Baseline and immediately after the intervention
Title
Self-efficacy
Description
1 question from New General Self-Efficacy Scale
Time Frame
Baseline and immediately after the intervention
Title
Patient health questionnaire 2-item scale (PHQ-2)
Description
Depression
Time Frame
Baseline and immediately after the intervention
Title
Generalized Anxiety Disorder 2-item scale (GAD-2)
Description
Anxiety
Time Frame
Baseline and immediately after the intervention
Title
Sleep
Description
Sleep questions from Patient Reported Outcome Measurement Information System (PROMIS-29) questionnaire
Time Frame
Baseline and immediately after the intervention
Title
Short Physical Performance Battery (SPPB)
Description
Measures of balance, gait speed, and chair stands
Time Frame
Baseline and immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Community-dwelling adults age 65+. Pre-frail (1-2 points on FRAIL scale) during pre-screening. Agree to participate and commit to all study procedures. Able to speak English. Access to and ability to use a smartphone, tablet, or computer and broadband internet. Exclusion criteria: Younger than age 65. Robust (0 points) or frail (3+ points) on FRAIL scale during phone screening. Established diagnosis of dementia. Untreated psychiatric symptoms affecting group participation. Hearing or visual impairment affecting participation in a virtual program.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Loewenthal, MD
Phone
617-525-7811
Email
jloewenthal@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Loewenthal, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Loewenthal, MD
Email
jloewenthal@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Julia Loewenthal, MD

12. IPD Sharing Statement

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AGE SELF CARE: Promoting Healthy Aging Through a Group Visit Program

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