Skip to main content
OpenTrials
Completed

NCT Number: NCT06079762

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AGE SELF CARE group visit program

Behavioral

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 outcomes

  1. Recruitment rate

    Time frame: Baseline

    Proportion of contacted potential participants who enrolled in the study

  2. Completion of testing

    Time frame: Baseline and immediately after the intervention

    Proportion of enrolled participants who completed testing for the study; time taken to complete testing

  3. Attendance

    Time frame: Immediately after the intervention

    Proportion of participants who attend at least 6 of 8 scheduled Zoom visits

  4. Completion of home practice log

    Time frame: Immediately after the intervention

    Proportion of of participants who complete the home practice log each week

  5. Participant satisfaction

    Time frame: Immediately after the intervention

    Participant satisfaction with program, visual analog scale from 1 to 10 (10 indicating highest satisfaction)

  6. Proportion lost to follow-up

    Time frame: Immediately after the intervention

    Proportion of enrolled participants who were lost to follow-up (unable to be contacted during study)

Secondary outcomes

  1. Frailty index

    Time frame: Baseline and immediately after the intervention

    Measurement of a frailty index based on the deficit accumulation model (PMID: 32072368)

  2. Loneliness

    Time frame: Baseline and immediately after the intervention

    University of California at Los Angeles 3-item Loneliness Questionnaire

  3. Self-reported health

    Time frame: Baseline and immediately after the intervention

    General health perception (from SF-12)

  4. Godin Leisure-Time Exercise Questionnaire

    Time frame: Baseline and immediately after the intervention

    Physical activity

  5. Self-efficacy

    Time frame: Baseline and immediately after the intervention

    1 question from New General Self-Efficacy Scale

  6. Patient health questionnaire 2-item scale (PHQ-2)

    Time frame: Baseline and immediately after the intervention

    Depression

  7. Generalized Anxiety Disorder 2-item scale (GAD-2)

    Time frame: Baseline and immediately after the intervention

    Anxiety

  8. Sleep

    Time frame: Baseline and immediately after the intervention

    Sleep questions from Patient Reported Outcome Measurement Information System (PROMIS-29) questionnaire

  9. Short Physical Performance Battery (SPPB)

    Time frame: Baseline and immediately after the intervention

    Measures of balance, gait speed, and chair stands

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2023
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.