Behavioral Activation for Independence in Older Veterans (ACTIVaTE) for Functional Independence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VA Bedford HealthCare System, Bedford, MA, Bedford, MA
Functional Independence
Behavioral Activation for Independence in Older Veterans (ACTIVaTE) - Behavioral
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

As Veterans age, chronic health conditions increase their risk of functional limitations, or difficulty completing day-to-day activities independently. Older adults with functional limitations are more likely to be hospitalized or admitted to long-term care facilities. Maintaining independence at home and in the community is a high priority for many older Veterans. The goal of this study is to support the physical, cognitive, and social functioning of older Veterans by developing a program based on behavioral activation, an evidence-based brief psychosocial intervention that helps individuals increase their engagement in activities aligned with their values (i.e. what matters most to them). The study consists of 3 aims. Aim 1 involves adapting an existing behavioral activation program for older Veterans at risk for functional decline to be delivered by video telehealth and seeking feedback from Veterans and VA staff about the program materials. Aim 2 involves testing the program in a group of 10 Veterans to learn whether it is satisfactory to Veterans; the investigators will make improvements to the program based on the information gathered in this aim. Aim 3 is a randomized controlled trial that will test the behavioral activation program compared to education about staying active in older adulthood in 48 Veterans. This will help determine whether the program is possible to deliver as planned and acceptable to Veterans, and assess the potential effects of the program on functioning an related health outcomes.

Treatment Effectiveness

Study Objectives

6 Primary · 8 Secondary · Reporting Duration: Baseline, 6 weeks, 12 weeks

12 weeks
Adherence
Barriers and facilitators
Fidelity
Perceived impact and recommendations
Retention at 12 weeks
Satisfaction at study completion
6 weeks
Satisfaction at intervention completion
Themes based on Theoretical Framework of Acceptability domains
Baseline
Enrollment
Randomization
Recruitment
Week 12
Change in behavioral activation as measured by the Behavioral Activation for Depression Scale - Short Form (BADS-SF)
Change in cognitive function as measured by the telephone Montreal Cognitive Assessment (T-MoCA)
Change in cognitive functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Applied Cognitive Scale
Change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
Change in engagement in physical, cognitive, and social activities as measured by the Community Healthy Activities Model Program for Seniors questionnaire (CHAMPS)
Change in physical function as measured by the Five Times Sit-to-Stand Test
Change in physical functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Daily Activities and Basic Mobility Scales
Change in quality of life as measured by the CDC Health-Related Quality of Life measure (HRQOL-4)
Change in social functioning as measured by the PROMIS Satisfaction with Social Roles and Activities (Short Form-8a)
Change in social isolation as measured by the PROMIS Social Isolation Scale (Short Form 4a)

Trial Safety

Trial Design

2 Treatment Groups

Attention control
1 of 2
ACTIVaTE intervention
1 of 2
Active Control
Experimental Treatment

58 Total Participants · 2 Treatment Groups

Primary Treatment: Behavioral Activation for Independence in Older Veterans (ACTIVaTE) · No Placebo Group · N/A

ACTIVaTE intervention
Behavioral
Experimental Group · 1 Intervention: Behavioral Activation for Independence in Older Veterans (ACTIVaTE) · Intervention Types: Behavioral
Attention control
Behavioral
ActiveComparator Group · 1 Intervention: Attention control · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 weeks, 12 weeks
Closest Location: VA Bedford HealthCare System, Bedford, MA · Bedford, MA
Photo of massachusetts 1Photo of massachusetts 2Photo of massachusetts 3
2021First Recorded Clinical Trial
1 TrialsResearching Functional Independence
2 CompletedClinical Trials

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,459 Previous Clinical Trials
2,748,855 Total Patients Enrolled
Meaghan A Kennedy, MD MPHPrincipal InvestigatorVA Bedford HealthCare System, Bedford, MA

Eligibility Criteria

Age 65+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are receiving VA primary care.
You are a community-dwelling resident.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.