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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Frail Elderly Syndrome; Frailty; Aging; Frailty Syndrome
• Intervention / Treatment: Behavioral: AGE SELF CARE group visit program

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia Loewenthal, MD; Phone Number: 617-525-7811; Email: jloewenthal@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
      • Contact: Julia Loewenthal, MD; Email: jloewenthal@bwh.harvard.edu
      • Principal Investigator: Julia Loewenthal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Community-dwelling adults age 65+.
2. Pre-frail (1-2 points on FRAIL scale) during pre-screening.
3. Agree to participate and commit to all study procedures.
4. Able to speak English.
5. Access to and ability to use a smartphone, tablet, or computer and broadband internet.

Exclusion criteria:

1. Younger than age 65.
2. Robust (0 points) or frail (3+ points) on FRAIL scale during phone screening.
3. Established diagnosis of dementia.
4. Untreated psychiatric symptoms affecting group participation.
5. Hearing or visual impairment affecting participation in a virtual program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AGE SELF CARE group visit program; Participants will take part in 8 weekly 90-minute virtual group visit program sessions

Behavioral: AGE SELF CARE group visit program; 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."

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Julia Loewenthal, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): March 29, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: September 29, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: yoga; mind-body; healthy aging; pre-frail
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Frailty
• Other Study ID Numbers: 2023P001407

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No