VOCALE: A Digital Intervention to Improve Quality of Life and Reduce Frailty Among Older Adults in Retirement Communities

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Washington

About this 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:

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • VOCALE Healthy Aging Online Program

    Behavioral

    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.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: VOCALE AGINGExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Baseline, 8 weeks, and 12 weeks (1-month follow-up)
2

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.

Time frame
Baseline, 8 weeks, and 12 weeks (1-month follow-up)
3

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.

Time frame
Baseline, 8 weeks, and 12 weeks (1-month follow-up)
4

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.

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

Other outcomes

1

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

The 25-item SPSI-R:S assesses five dimensions of problem solving: Positive Problem Orientation, Negative Problem Orientation, Rational Problem Solving, Impulsivity/Carelessness Style, and Avoidance Style. Each subscale ranges from 0 to 20. Higher Positive Problem Orientation and Rational Problem Solving scores and lower Negative Problem Orientation, Impulsivity/Carelessness, and Avoidance scores indicate more effective problem solving. An overall score can also be calculated, with higher scores indicating better problem-solving ability.

Time frame
Baseline, 5, 8 weeks, and 12 weeks (1-month follow-up)
2

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

The 19-item Medical Outcomes Study (MOS) Social Support Survey assesses perceived availability of social support across emotional/informational, tangible, affectionate, and positive social interaction domains. Scores are transformed to a 0-100 scale, with higher scores indicating greater perceived social support.

Time frame
Baseline, 5, 8 and 12 weeks
3

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

The 10-item General Self-Efficacy Scale (GSES) assesses confidence in one's ability to cope with difficult or challenging situations. Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.

Time frame
Baseline, 5, 8 and 12 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

National Institute on Aging (NIA)

Collaborator

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