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Behavioral Activation for Functional Independence in Older Veterans (ACTIVaTE Trial)
N/A
Recruiting
Led By Meaghan A Kennedy, MD MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 12 weeks
Awards & highlights
ACTIVaTE Trial Summary
This trial is testing a program to help older Veterans stay independent by being active in things they care about. The program is being delivered by video telehealth.
Who is the study for?
This trial is for older Veterans who may struggle with day-to-day activities due to chronic health issues. They must be at risk of losing their independence, receiving VA primary care, living outside nursing homes, and able to give consent. Those with severe depression or certain mental health conditions, upcoming surgeries, or in hospice care cannot join.Check my eligibility
What is being tested?
The study tests a program called ACTIVaTE delivered via video telehealth against an education program about staying active. It aims to improve physical, cognitive, and social functions by increasing engagement in meaningful activities. The effectiveness will be measured through a randomized controlled trial involving 48 Veterans.See study design
What are the potential side effects?
Since this intervention involves behavioral activation rather than medication or invasive procedures, side effects are minimal but could include potential discomfort from discussing personal values and increased activity levels.
ACTIVaTE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 weeks, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence
Enrollment
Retention at 12 weeks
+3 moreSecondary outcome measures
Barriers and facilitators
Change in cognitive functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Applied Cognitive Scale
Change in physical functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Daily Activities and Basic Mobility Scales
+5 moreOther outcome measures
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 depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
+4 moreACTIVaTE Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Open trialExperimental Treatment1 Intervention
In Aim 2, all 10 participants will receive the ACTIVaTE intervention.
Group II: ACTIVaTE interventionExperimental Treatment1 Intervention
In Aim 3, 24 participants will be randomized to receive the ACTIVaTE intervention.
Group III: Attention controlActive Control1 Intervention
In Aim 3, 24 participants will be randomized to an attention control arm.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,371 Total Patients Enrolled
Meaghan A Kennedy, MD MPHPrincipal InvestigatorVA Bedford HealthCare System, Bedford, MA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have thoughts of harming myself.I have not had psychosis in the last 6 months.I am currently in physical, occupational, or psychotherapy.I do not speak English.I am mentally and physically stable to give consent.I have advanced cognitive impairment.I do not have schizophrenia.I do not have severe hearing or vision problems that would stop me from joining.I do not have any surgeries planned in the next 3 months.I am not in hospice or receiving palliative care for an unstable health condition.I do not have severe depression (PHQ-9 score less than 14).
Research Study Groups:
This trial has the following groups:- Group 1: Open trial
- Group 2: ACTIVaTE intervention
- Group 3: Attention control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What key goals has this study been designed to achieve?
"The aim of this 12-week investigation is to evaluate enrollment. Secondary objectives include assessing changes in physical and cognitive functioning, as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Daily Activities and Basic Mobility Scales, Applied Cognitive Scale, respectively. Moreover, fidelity will be quantified using a mean score from the intervention checklist with 80% being deemed feasible success rate."
Answered by AI
Are there still opportunities for participation in this research program?
"Data on clinicaltrials.gov reveals that this medical trial is no longer enrolling patients, as it was last updated on September 7th 2022. Nevertheless, 3 other studies are actively seeking candidates at the present moment."
Answered by AI
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