Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288438
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-02-23
Brief Title:
Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of ComplexHealth Conditions
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Medically complex older Veterans are at greater risk for progressive declines in physical function lower quality of life and increasing care needs Additionally older Veterans experience social isolation and loneliness and have low levels of physical activity While the Veterans Health Administration has established programs to address rehabilitation needs these programs tend to be diagnosis-focused lack self-management approaches include low-intensity rehabilitation and typically require in-person attendance A MultiComponent TeleRehabilitation MCTR program that includes high-intensity rehabilitation and self-management interventions social support and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions Therefore this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions
Detailed Description:
The proposed MultiComponent TeleRehabilitation MCTR program addresses current healthcare deficiencies by using a multicomponent approach that includes both high-intensity rehabilitation interventions and self-management interventions that are not part of traditional physical therapy interventions Therefore the investigators propose a two-arm parallel randomized trial using a crossover study design to determine the effectiveness AIM 1 of a 12-week multicomponent telerehabilitation program to improve physical function The investigators will also measure Veterans clinical outcomes to evaluate the effectiveness of the MCTR program to improve physical activity health self-management and self-reported health AIM 2 Lastly the investigators will explore the effects of the MCTR program on safety events such as emergency room visits hospitalizations falls and other adverse events AIM 3 Participants n126 will be randomized to MCTR or Control group using computer-generated random blocks stratified by sex The MCTR group will participate in the 24-week program consisting of 1 progressive high-intensity rehabilitation 2 self-management interventions 3 social support and 4 technology supports The 12-week program is split into three phases the Active Phase weeks 1-6 the Transition Phase weeks 7-12 and the Sustainability Phase weeks 13-24 The Control group will participate in education and health status update sessions in parallel to the MCTR 12-week program Outcomes will be collected at baseline 6 weeks 12 weeks primary endpoint and 24 weeks Achievement of the proposed aims will provide evidence to expand high quality telerehabilitation services for medically complex older Veterans with multiple factors contributing to poor health eg social isolation loneliness physical inactivity poor self-management Importantly results will guide the advancement of rehabilitation practices moving away from a traditionally narrow episodic diagnosis-focused approach to a model emphasizing whole health self-management and sustained healthy living Study findings will have immediate clinical impact as they will be directly translatable to other medically complex and underserved populations who will benefit from innovative telerehabilitation care approaches
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23-2306 | OTHER | COMIRB | None |