NCT07860892

Brief Summary

The goal of this clinical trial is to learn whether an 8-week online program called VOCALE can improve quality of life and reduce frailty in adults age 65 and older who live independently in retirement communities and have mild to moderate frailty. The main questions it aims to answer are:

  • Does participating in VOCALE improve participants' quality of life?
  • Does participating in VOCALE reduce frailty?
  • Do changes in problem-solving skills, self-confidence in managing health, and social support help explain how VOCALE may affect quality of life and frailty? Researchers will compare participants in retirement communities assigned to the VOCALE program with participants in communities assigned to usual care and educational resources to see whether VOCALE improves quality of life and frailty. Participants will:
  • Complete assessments of their health, quality of life, frailty, and related measures at the beginning of the study, after 8 weeks, and one month later.
  • Complete physical performance assessments.
  • If assigned to VOCALE, receive training on the online platform and participate in moderated online discussions about healthy aging, health challenges, and problem-solving for 8 weeks.
  • If assigned to the comparison group, continue with usual care and receive educational materials and healthy aging resources.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
49mo left

Started Jan 2027

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 6, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2027

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2031

Last Updated

October 6, 2026

Status Verified

September 1, 2026

Enrollment Period

4 years

First QC Date

September 24, 2026

Last Update Submit

September 30, 2026

Conditions

Keywords

FrailtyRetirement CommunityCCRCBehavioralOnline

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life measured by the RAND 36-Item Health Survey (RAND-36)

    The RAND 36-Item Health Survey assesses health-related quality of life across eight domains, including physical functioning, bodily pain, role limitations, emotional well-being, social functioning, energy/fatigue, and general health. Scores are transformed to a 0-100 scale, with higher scores indicating better health-related quality of life.

    Baseline, 8 weeks, and 12 weeks (1-month follow-up)

Secondary Outcomes (5)

  • Frailty measured by the Fried Frailty Phenotype

    Baseline, 8 weeks, and 12 weeks (1-month follow-up)

  • Physical performance measured by the Short Physical Performance Battery (SPPB)

    Baseline, 8 weeks, and 12 weeks (1-month follow-up)

  • Loneliness measured by the 3-item Revised UCLA Loneliness Scale

    Baseline, 8 weeks, and 12 weeks (1-month follow-up)

  • Depressive symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-D)

    Baseline, 8 weeks, and 12 weeks (1-month follow-up)

  • Perceived stress measured by the 10-item Perceived Stress Scale (PSS-10)

    Baseline, 8 weeks, and 12 weeks (1-month follow-up)

Other Outcomes (3)

  • Problem-solving skills measured by the Social Problem-Solving Inventory-Revised: Short Form (SPSI-R:S)

    Baseline, 5, 8 weeks, and 12 weeks (1-month follow-up)

  • Social support measured by the Medical Outcomes Study (MOS) Social Support Survey

    Baseline, 5, 8 and 12 weeks

  • Self-efficacy measured by the General Self-Efficacy Scale (GSES)

    Baseline, 5, 8 and 12 weeks

Study Arms (2)

VOCALE AGING

EXPERIMENTAL

Participants assigned to the VOCALE intervention will receive an 8-week online, group-based program focused on healthy aging, frailty, and problem-solving. Participants will receive training on how to use the private online discussion platform and will be encouraged to access the platform at least twice per week. Weekly moderated discussions will address health challenges related to frailty and teach participants problem-solving skills using the ADAPT approach: adopting a positive attitude, defining the problem, brainstorming alternatives, predicting consequences, and trying out a solution. Participants may also receive technical support and additional training as needed.

Behavioral: VOCALE Healthy Aging Online Program

Control

NO INTERVENTION

Participants assigned to the control arm will continue to receive their usual care and services. They will also receive educational materials about self-management and problem-solving, along with a list of healthy aging resources from the National Institute on Aging. They will not participate in the VOCALE online discussion program during the study period.

Interventions

VOCALE Healthy Aging is an 8-week, group-based online behavioral intervention designed to support older adults with mild to moderate frailty. The intervention is delivered through a private, moderated online discussion platform and combines peer interaction with structured problem-solving training. Participants discuss common health and aging challenges and learn and practice the ADAPT problem-solving approach: adopting a positive attitude, defining the problem, brainstorming alternatives, predicting consequences, and trying out a chosen solution. Participants can access the platform asynchronously and receive training and technical support as needed.

VOCALE AGING

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years and older
  • Evidence of mild to moderate frailty based on scores of 4-6 according to the Clinical Frailty Scale (CFS)
  • Resident in a retirement community in Seattle area

You may not qualify if:

  • Having difficulty with basic activities of daily living such as eating and getting out of bed
  • Having a Memory Impairment Screen for Telephone (MIS-T) score of \<3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FrailtyBehavior

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Oleg Zaslavsky, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oleg Zaslavsky, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 24, 2026

First Posted

October 6, 2026

Study Start (Estimated)

January 15, 2027

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

January 30, 2031

Last Updated

October 6, 2026

Record last verified: 2026-09