Clinical trial NCT05493241: Behavioral Activation for Independence in Older Veterans
Official title: Development and Feasibility of a Behavioral Activation Intervention to Support Independence in Older Veterans at Risk for Functional Decline
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Independence
Keywords: functional status
aged
psychosocial intervention
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-08-09
Enrollment: 58
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants in Aim 2 (open trial, single arm) will all receive the ACTIVaTE intervention. Participants in Aim 3 (randomized controlled trial) will be randomly assigned to the ACTIVaTE intervention or usual care.
Primary purpose: TREATMENT

Brief 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 usual care 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 and related health outcomes.

Detailed description: The overarching goal of this study is to develop and test the feasibility and acceptability of a telehealth-delivered behavioral activation (BA) intervention (ACTIVaTE) to promote physical, cognitive, and social functioning in community-dwelling older Veterans at risk for functional decline. This work will provide preliminary data that will inform the design of a future adequately-powered efficacy trial.

This proposal consists of three aims: Aims 1 and 2 are focused on intervention adaptation and refinement of an existing BA model to optimize the acceptability of the ACTIVaTE intervention and study procedures for older Veterans (NIH Stage Model for Behavioral Intervention Development stage IA). Aim 3 is a feasibility pilot RCT of the ACTIVaTE intervention versus usual care (NIH Stage Model stage IB). A focus on Stage I procedures (intervention generation and refinement, including initial feasibility pilot testing) will ensure that the intervention is optimally tailored to the study population and feasible for subsequent stage II-IV efficacy and effectiveness testing. Mixed methods will be used throughout all aims to optimize the intervention for the VA and telehealth delivery, to incorporate Veterans' preference into the intervention and study design, and to understand barriers and facilitators to implementation during the pilot phase.

Aim 1: Adapt BA protocol for ACTIVaTE (Year 1). The investigators will develop ACTIVaTE based on an existing BA model (Behavioral Activation Treatment for Depression-Revised) for delivery to older Veterans at risk for functional decline via the VA's video telehealth platform (VA Video Connect). The previous experience with BA will inform the initial adaptation, incorporating perspectives from primary care, geropsychology, and occupational therapy. The investigators will seek feedback on the preliminary manual and participant workbook via semi-structured interviews with VA psychologists (n=5), occupational therapists (n=5), and Veterans (n=5), using findings from rapid qualitative analysis to further modify the materials. By design, this intervention development aim is hypothesis-generating as opposed to hypothesis-driven, as the investigators will be using qualitative methods to extract themes that will guide intervention adaptation and refine subsequent aims.

Aim 2: Refine the ACTIVaTE intervention (Year 2). Preliminary acceptability of the intervention will be established through a small open trial of the intervention delivered via VVC to 10 older Veterans at risk for functional decline (Vulnerable Elders Survey-13 score 3) recruited from VA primary care. This early acceptability testing will focus on Veteran satisfaction and experience with the intervention and study procedures and will also be used to optimize interventionist training and fidelity assessment. Participants will complete qualitative interviews guided by the Theoretical Framework of Acceptability (TFA) as well as the Client Satisfaction Questionnaire (CSQ) and findings will be used to further refine the intervention materials prior to the pilot RCT. The investigators hypothesize that the intervention will be preliminarily acceptable as determined by high CSQ scores ( 80%) among at least 70% of participants. The investigators also anticipate that themes identified within TFA domains will demonstrate general acceptability with some recommendations to inform refinement.

Aim 3: Determine feasibility, acceptability, and preliminary impact of ACTIVaTE (Years 3-4). The investigators will conduct a 1:1 randomized pilot RCT of ACTIVaTE versus usual care in 48 Veterans at risk for functional decline (VES-13 score 3) recruited from VA primary care. The primary goal of the pilot RCT is to establish feasibility and acceptability, and a fully powered RCT is beyond the scope of this study. However, the investigators will explore preliminary evidence of potential impact on functioning. The investigators will collect clinical measures at baseline, 8 weeks, and 12 weeks, using the Ambulatory Measure for Post-Acute Care (AM-PAC) and PROMIS Satisfaction with Social Roles and Activities as primary measures of physical, cognitive, and social functioning. The investigators will also conduct semi-structured interviews with a purposive sample of participants based on satisfaction and adherence. Exploratory outcomes include objective physical and cognitive function, quality of life, mood, behavioral activation, social isolation, and engagement in physical, cognitive, and social activities.

Aim 3a: Feasibility will be determined by enrollment and retention. Acceptability will be determined by adherence and satisfaction, as well as by themes from qualitative interviews. The investigators hypothesize that the intervention will be feasible (enrollment of 2-3 participants per month for a total n=48; retention of at least 80% of participants at 12 weeks follow-up) and acceptable ( 80% of participants complete at least 5/6 sessions; 70% of participants report high satisfaction on Client Satisfaction Questionnaire).

Aim 3b: Preliminary impact on AM-PAC and PROMIS will be explored through within and between groups mixed-effects linear regression models and proportions of participants who achieve minimal clinically important change in outcomes. The investigators hypothesize that a greater proportion of participants in the ACTIVaTE group will achieve minimal clinically important change in AM-PAC and PROMIS than usual care.

Eligibility criteria: Inclusion Criteria:

* Receiving VA primary care
* Community-dwelling (living outside nursing homes)
* At risk for functional decline (VES-13 score 3 or higher); (Aim 3 only) For individuals who are age 85 and score 3 on VES based on age alone, we will also require that they have a score of 0.2 on the VA frailty index (mild frailty or greater)

Exclusion Criteria:

* Non-English speaking
* Currently receiving physical therapy, occupational therapy, or psychotherapy
* Advanced cognitive impairment (MIS-T 3 or lower)
* Uncorrectable hearing or visual impairment that would preclude participation
* Unstable physical or mental health condition:

  * ongoing evaluation of new cardiac or respiratory symptoms
  * receiving hospice or palliative care services
  * anticipated surgery in the next 3 months
  * severe depressive symptoms (PHQ-9 14 or higher)
  * active suicidal ideation
  * likely substance use disorder (positive TICS)
  * schizophrenia
  * psychosis in the past 6 months
* (Aim 2 and 3) Currently receiving physical therapy, occupational therapy, or psychotherapy
* (Aim 3 only) No access to video-capable device (tablet, smartphone, computer) for VVC visits

Primary outcomes:
measure: Enrollment
timeFrame: Baseline
measure: Retention at 12 weeks
timeFrame: 12 weeks
measure: Adherence
timeFrame: 12 weeks
measure: Satisfaction at intervention completion
timeFrame: 6 weeks
measure: Themes based on Theoretical Framework of Acceptability domains
timeFrame: 6 weeks
measure: Satisfaction at study completion
timeFrame: 12 weeks
Secondary outcomes:
measure: Recruitment
timeFrame: Baseline
measure: Change in physical functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Daily Activities and Basic Mobility Scales
timeFrame: Baseline, 6-8 weeks, 12 weeks
measure: Randomization
timeFrame: Baseline
measure: Change in cognitive functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Applied Cognitive Scale
timeFrame: Baseline, 6-8 weeks, 12 weeks
measure: Fidelity
timeFrame: 12 weeks
measure: Change in social functioning as measured by the PROMIS Satisfaction with Social Roles and Activities (Short Form-8a)
timeFrame: Baseline, 6-8 weeks, 12 weeks
measure: Barriers and facilitators
timeFrame: 12 weeks
measure: Perceived impact and recommendations
timeFrame: 12 weeks
Other outcomes:
measure: Change in physical function as measured by the Five Times Sit-to-Stand Test
timeFrame: Baseline, 6 weeks
measure: Change in cognitive function as measured by the telephone Montreal Cognitive Assessment (T-MoCA)
timeFrame: Baseline, 6-8 weeks, 12 weeks
measure: Change in behavioral activation as measured by the Behavioral Activation for Depression Scale - Short Form (BADS-SF)
timeFrame: Baseline, 6 weeks
measure: Change in engagement in physical, cognitive, and social activities as measured by the Community Healthy Activities Model Program for Seniors questionnaire (CHAMPS)
timeFrame: Baseline, 6-8 weeks, 12 weeks
measure: Change in quality of life as measured by the CDC Health-Related Quality of Life measure (HRQOL-4)
timeFrame: Baseline, 6 weeks
measure: Change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 6-8 weeks, 12 weeks
measure: Change in values-aligned living as measured by the Valuing Questionnaire
timeFrame: Baseline, 8 weeks, 12 weeks
measure: Change in social isolation as measured by the PROMIS Social Isolation Scale (Short Form 4a)
timeFrame: Baseline, 6-8 weeks, 12 weeks
measure: Change in global functioning as measured by the World Health Organization Disability Assessment Scale (WHODAS 2.0)
timeFrame: Baseline, 8 weeks, 12 weeks
measure: Change in care engagement as measured by number of health care visits
timeFrame: Baseline, 8 weeks, 12 weeks
Locations:
city: Bedford
country: United States
facility: VA Bedford HealthCare System, Bedford, MA
state: Massachusetts
Study officials:
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Meaghan A Kennedy, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: