FrailtyVOCALE AGINGNCT07860892
VOCALE: A Digital Intervention to Improve Quality of Life and Reduce Frailty Among Older Adults in Retirement Communities
A study testing VOCALE Healthy Aging Online Program in people with Frailty and Quality of Life, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Quality of Life
- What is being tested?
- VOCALE Healthy Aging Online Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2027to 30 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: VOCALE: A Digital Intervention to Improve Quality of Life and Reduce Frailty Among Older Adults in CCRCs - A Randomized Controlled Trial
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:
Read more
- 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.
- Conditions
- Frailty, Quality of Life
- Being tested
- VOCALE Healthy Aging Online Program
- Keywords
- Frailty, Retirement Community, CCRC, Behavioral, Online
- Medical subject headings
- Frailty, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOCALE Healthy Aging Online ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks, and 12 weeks (1-month follow-up)
Secondary outcomes (5)
Frailty measured by the Fried Frailty Phenotype
The Fried Frailty Phenotype assesses five criteria: unintentional weight loss, weakness (grip strength), exhaustion, slow walking speed, and low physical activity. The total score ranges from 0 to 5, with higher scores indicating greater frailty. A score of 0 indicates robustness, 1-2 indicates pre-frailty, and 3-5 indicates frailty.
Measured: Baseline, 8 weeks, and 12 weeks (1-month follow-up)
Physical performance measured by the Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery (SPPB) assesses lower-extremity function using three components: balance, gait speed, and chair stands. Component scores are combined for a total score ranging from 0 to 12, with higher scores indicating better physical performance.
Measured: Baseline, 8 weeks, and 12 weeks (1-month follow-up)
Loneliness measured by the 3-item Revised UCLA Loneliness Scale
The 3-item Revised UCLA Loneliness Scale assesses subjective feelings of loneliness and social isolation. Total scores range from 0 to 6, with higher scores indicating greater loneliness.
Measured: Baseline, 8 weeks, and 12 weeks (1-month follow-up)
Depressive symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
The 20-item Center for Epidemiologic Studies Depression Scale (CES-D) assesses the frequency of depressive symptoms experienced during the past week. Total scores range from 0 to 60, with higher scores indicating more severe depressive symptoms.
Measured: Baseline, 8 weeks, and 12 weeks (1-month follow-up)
Perceived stress measured by the 10-item Perceived Stress Scale (PSS-10)
The 10-item Perceived Stress Scale (PSS-10) assesses the degree to which situations in one's life are perceived as stressful. Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Measured: Baseline, 8 weeks, and 12 weeks (1-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start15 Jan 2027 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Oleg Zaslavsky, University of Washington
- Investigators
- Oleg Zaslavsky, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860892
- Sponsor's protocol ID
- R01AG088115
- Other IDs
- R01AG088115
- Acronym
- VOCALE AGING
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VOCALE: A Digital Intervention to Improve Quality of Life and Reduce Frailty Among Older Adults in CCRCs - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07860892
- Acronym / sponsor ID
- VOCALE AGING / R01AG088115
- Conditions
- Frailty, Quality of Life
- Keywords
- Frailty, Retirement Community, CCRC, Behavioral, Online
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 30 Jan 2031 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VOCALE AGING | Experimental | Behavioral: VOCALE Healthy Aging Online ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOCALE Healthy Aging Online ProgramVOCALE 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. | Behavioural | VOCALE AGING |
Primary outcome
Health-related quality of life measured by the RAND 36-Item Health Survey (RAND-36)
Time frame: Baseline, 8 weeks, and 12 weeks (1-month follow-up)
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.
5 secondary outcomes
Frailty measured by the Fried Frailty Phenotype
Time frame: Baseline, 8 weeks, and 12 weeks (1-month follow-up)
Physical performance measured by the Short Physical Performance Battery (SPPB)
Time frame: Baseline, 8 weeks, and 12 weeks (1-month follow-up)
Loneliness measured by the 3-item Revised UCLA Loneliness Scale
Time frame: Baseline, 8 weeks, and 12 weeks (1-month follow-up)
Depressive symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline, 8 weeks, and 12 weeks (1-month follow-up)
Perceived stress measured by the 10-item Perceived Stress Scale (PSS-10)
Time frame: Baseline, 8 weeks, and 12 weeks (1-month follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oleg Zaslavsky, PhD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing VOCALE Healthy Aging Online Program in people with Frailty and Quality of Life, run by University of Washington.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oleg Zaslavsky, PhD (2068493301, ozasl@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life measured by the RAND 36-Item Health Survey (RAND-36) (time frame: Baseline, 8 weeks, and 12 weeks (1-month follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.