Development and Feasibility of a Behavioral Activation Intervention to Support Independence in Older Veterans at Risk for Functional Decline
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Enrollment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
In Aim 3, a research coordinator masked to group assignment will conduct the 8- and 12-week assessments.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
ACTIVaTE intervention
In Aim 3, 24 participants will be randomized to receive the ACTIVaTE intervention.
干预措施: Behavioral Activation for Independence in Older Veterans (ACTIVaTE) (Behavioral)
Open trial
In Aim 2, all 10 participants will receive the ACTIVaTE intervention.
干预措施: Behavioral Activation for Independence in Older Veterans (ACTIVaTE) (Behavioral)
ACTIVaTE intervention
In Aim 3, 24 participants will be randomized to receive the ACTIVaTE intervention.
干预措施: Usual care (Other)
Usual care
In Aim 3, 24 participants will be randomized to a usual care arm.
干预措施: Usual care (Other)
结局指标
主要结局
Enrollment
时间窗: Baseline
Proportion screened who enroll; number or participants enrolled per month; total number of participants enrolled. Enrollment will serve as a measure of feasibility in Aim 3, with a benchmark of 2-3 Veterans enrolled per month to achieve a sample of 48 participants enrolled over 18 months.
Satisfaction at intervention completion
时间窗: 6 weeks
Proportion reporting high satisfaction (at least 80% on the Client Satisfaction Questionnaire \[CSQ-8\]). Satisfaction at intervention completion (6 weeks) will serve as a measure of acceptability in Aim 2 with a benchmark of at least 70% of participants report high satisfaction. Validated measure of treatment satisfaction in mental health and research settings; raw scores will be transformed to a 100-point percentage scale.
Retention at 12 weeks
时间窗: 12 weeks
Proportion enrolled who complete 12wk follow-up. Retention will serve as a measure of feasibility in Aim 3, with a benchmark of at least 80% of participants enrolled completing the 12wk follow-up.
Adherence
时间窗: 12 weeks
Proportion completing at least 5 of 6 sessions. Adherence will serve as a measure of acceptability in Aim 3 with a benchmark of At least 80% of participants completing 5-6 sessions.
Themes based on Theoretical Framework of Acceptability domains
时间窗: 6 weeks
Themes regarding acceptability of the intervention based on the Theoretical Framework of Acceptability as determined by participant semi-structured interviews. This will serve as a measure of acceptability in Aim 2.
Satisfaction at study completion
时间窗: 12 weeks
Proportion reporting high satisfaction (at least 80% on the Client Satisfaction Questionnaire \[CSQ-8\]). Satisfaction at study completion (12 weeks) will serve as a measure of acceptability in Aim 3 with a benchmark of at least 70% of participants report high satisfaction. Validated measure of treatment satisfaction in mental health and research settings; raw scores will be transformed to a 100-point percentage scale.
次要结局
- Change in physical functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Daily Activities and Basic Mobility Scales(Baseline, 6-8 weeks, 12 weeks)
- Fidelity(12 weeks)
- Change in cognitive functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Applied Cognitive Scale(Baseline, 6-8 weeks, 12 weeks)
- Change in social functioning as measured by the PROMIS Satisfaction with Social Roles and Activities (Short Form-8a)(Baseline, 6-8 weeks, 12 weeks)
- Perceived impact and recommendations(12 weeks)
- Randomization(Baseline)
- Barriers and facilitators(12 weeks)
- Recruitment(Baseline)