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FrailtyNCT06079762

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

A study testing AGE SELF CARE group visit program in people with Frailty and Aging, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 to 110 years
Conditions the study is for
Frailty, Aging, Frailty Syndrome
What is being tested?
AGE SELF CARE group visit program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
1 Oct 2023to 5 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 110 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Read more

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.

Read the 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.

Being tested
AGE SELF CARE group visit program
Keywords
yoga, mind-body, pre-frail, healthy aging
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGE SELF CARE group visit programBehavioural

    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."

Study groups in NCT06079762
Study groupRoleWhat they receive
AGE SELF CARE group visit programExperimentalParticipants will take part in 8 weekly 90-minute virtual group visit program sessions
Receives: Behavioral: AGE SELF CARE group visit program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Proportion of contacted potential participants who enrolled in the study

    Measured: Baseline

  2. Completion of testing

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

    Measured: Baseline and immediately after the intervention

  3. Attendance

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

    Measured: Immediately after the intervention

  4. Completion of home practice log

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

    Measured: Immediately after the intervention

  5. Participant satisfaction

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

    Measured: Immediately after the intervention

  6. Proportion lost to follow-up

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

    Measured: Immediately after the intervention

Secondary outcomes (9)

  1. Frailty index

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

    Measured: Baseline and immediately after the intervention

  2. Loneliness

    University of California at Los Angeles 3-item Loneliness Questionnaire

    Measured: Baseline and immediately after the intervention

  3. Self-reported health

    General health perception (from SF-12)

    Measured: Baseline and immediately after the intervention

  4. Godin Leisure-Time Exercise Questionnaire

    Physical activity

    Measured: Baseline and immediately after the intervention

  5. Self-efficacy

    1 question from New General Self-Efficacy Scale

    Measured: Baseline and immediately after the intervention

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

    Depression

    Measured: Baseline and immediately after the intervention

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

    Anxiety

    Measured: Baseline and immediately after the intervention

  8. Sleep

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

    Measured: Baseline and immediately after the intervention

  9. Short Physical Performance Battery (SPPB)

    Measures of balance, gait speed, and chair stands

    Measured: Baseline and immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start1 Oct 2023
  3. Primary completion29 Mar 2024
  4. Study completion5 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
single-group feasibility/acceptability, stage I (NIH stage model for behavioral intervention development)
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06079762
Sponsor's protocol ID
2023P001407
Status last verified
Aug 2024
First submitted
29 Sep 2023
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing AGE SELF CARE group visit program in people with Frailty and Aging, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06079762.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.

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