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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06079762
• Other study ID #: 2023P001407
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: May 31, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Frail Elderly Syndrome
• Frailty
• Frailty Syndrome
• Syndrome

Intervention

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."

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Proportion of contacted potential participants who enrolled in the study	Baseline
Primary	Completion of testing	Proportion of enrolled participants who completed testing for the study; time taken to complete testing	Baseline and immediately after the intervention
Primary	Attendance	Proportion of participants who attend at least 6 of 8 scheduled Zoom visits	Immediately after the intervention
Primary	Completion of home practice log	Proportion of of participants who complete the home practice log each week	Immediately after the intervention
Primary	Participant satisfaction	Participant satisfaction with program, visual analog scale from 1 to 10 (10 indicating highest satisfaction)	Immediately after the intervention
Primary	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	Frailty index	Measurement of a frailty index based on the deficit accumulation model (PMID: 32072368)	Baseline and immediately after the intervention
Secondary	Loneliness	University of California at Los Angeles 3-item Loneliness Questionnaire	Baseline and immediately after the intervention
Secondary	Self-reported health	General health perception (from SF-12)	Baseline and immediately after the intervention
Secondary	Godin Leisure-Time Exercise Questionnaire	Physical activity	Baseline and immediately after the intervention
Secondary	Self-efficacy	1 question from New General Self-Efficacy Scale	Baseline and immediately after the intervention
Secondary	Patient health questionnaire 2-item scale (PHQ-2)	Depression	Baseline and immediately after the intervention
Secondary	Generalized Anxiety Disorder 2-item scale (GAD-2)	Anxiety	Baseline and immediately after the intervention
Secondary	Sleep	Sleep questions from Patient Reported Outcome Measurement Information System (PROMIS-29) questionnaire	Baseline and immediately after the intervention
Secondary	Short Physical Performance Battery (SPPB)	Measures of balance, gait speed, and chair stands	Baseline and immediately after the intervention