RECRUITING

Behavioral Activation for Independence in Older Veterans

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Development and Feasibility of a Behavioral Activation Intervention to Support Independence in Older Veterans at Risk for Functional Decline

Quick Facts

Study Start:2024-02-12
Study Completion:2026-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05493241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Receiving VA primary care
  2. * Community-dwelling (living outside nursing homes)
  3. * 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)
  1. * Non-English speaking
  2. * Currently receiving physical therapy, occupational therapy, or psychotherapy
  3. * Advanced cognitive impairment (MIS-T 3 or lower)
  4. * Uncorrectable hearing or visual impairment that would preclude participation
  5. * Unstable physical or mental health condition:
  6. * ongoing evaluation of new cardiac or respiratory symptoms
  7. * receiving hospice or palliative care services
  8. * anticipated surgery in the next 3 months
  9. * severe depressive symptoms (PHQ-9 14 or higher)
  10. * active suicidal ideation
  11. * likely substance use disorder (positive TICS)
  12. * schizophrenia
  13. * psychosis in the past 6 months
  14. * (Aim 2 and 3) Currently receiving physical therapy, occupational therapy, or psychotherapy
  15. * (Aim 3 only) No access to video-capable device (tablet, smartphone, computer) for VVC visits

Contacts and Locations

Study Contact

Meaghan A Kennedy, MD MPH
CONTACT
(412) 688-6000
Meaghan.Kennedy@va.gov

Principal Investigator

Meaghan A Kennedy, MD MPH
PRINCIPAL_INVESTIGATOR
VA Bedford HealthCare System, Bedford, MA

Study Locations (Sites)

VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Meaghan A Kennedy, MD MPH, PRINCIPAL_INVESTIGATOR, VA Bedford HealthCare System, Bedford, MA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12
Study Completion Date2026-10-31

Study Record Updates

Study Start Date2024-02-12
Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

  • functional status
  • aged
  • psychosocial intervention
  • Veterans

Additional Relevant MeSH Terms

  • Functional Independence