Recruiting

CTraC-FIT

Sponsor:

VA Office of Research and Development

Code:

NCT07132944

Conditions

Functional Impairment

Functional Performance

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

CTraC-FIT

Enhanced Usual Care

Study Details

Brief summary:

Functional decline after hospitalization is a serious concern for older Veterans, often leading to loss of independence and disability. VA's nurse-led Coordinated Transitional Care (CTraC) program has demonstrated success in improving care transitions, but currently lacks targeted assessment and intervention to support Veterans' functional recovery. This project aims to develop and test a function-focused CTraC protocol (CTraC-FIT) to address this critical gap and optimize functional outcomes for Veterans transitioning from hospital to home. By integrating evidence-based functional assessment and intervention strategies into the CTraC protocol, this project aims to empower Veterans to regain and maintain their independence and improve their quality of life.

Conditions

Functional Impairment

Functional Performance

Study ID

NCT07132944

Start date

Jul 1, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Score of > 3 on Vulnerable Elders Survey, (VES-13)
  • Score of 4-9 on Short Physical Performance Battery (SPPB)
  • Able to provide informed consent

Exclusion Criteria:

  • Admitted to VA Boston for acute psychiatric are or substance abuse detoxification
  • Plan to discharge anywhere except home (e.g., assisted living, group home, or skilled nursing facility)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: CTraC-FIT

The intervention arm involves participants receiving a structured transitional care intervention (CTraC-FIT) administered by a trained nurse case manager via phone or VA Video Connect, aimed at improving functional abilities and reducing hospital readmissions.

other: Enhanced Usual Care

The Enhanced Usual Care (EUC) arm involves participants receiving the standard care provided by their assigned Veterans Affairs Boston Healthcare System (VABHS) inpatient and outpatient teams.

Interventions

CTraC-FIT

The intervention is designed to support Veterans at high risk of readmission with comprehensive transitional care that includes:

Structured Follow-Ups: Regularly scheduled follow-up calls to monitor the patient's progress, address any issues, and provide ongoing support.

Health Coaching: Personalized coaching to help Veterans manage their health conditions, adhere to treatment plans, and make lifestyle changes that can improve their overall health.

Care Coordination: Assistance with navigating the healthcare system, facilitating appointments, and ensuring that the Veteran receives all necessary post-discharge services.

The intervention arm aims to improve functional abilities and reduce hospital readmissions by providing tailored support based on the unique needs of each participant. The CTraC NCM will follow a standardized protocol to ensure consistent and effective delivery of the intervention across all participants in this group.

Enhanced Usual Care

The Enhanced Usual Care (EUC) arm involves participants receiving the standard care provided by their assigned Veterans Affairs Boston Healthcare System (VABHS) inpatient and outpatient teams. This includes routine medical evaluations, treatments, and follow-up appointments as typically recommended by their healthcare providers. In addition to receiving standard care, participants in the EUC group will undergo baseline, endpoint, and 3-month follow-up assessments as part of the study protocol.

For participants with intermediate functional ability (SPPB score of 7-9), no additional intervention will be provided after randomization to the control group. However, for participants with low functional ability (SPPB score of 0-6), a safety protocol will be activated to notify their assigned inpatient medical team (e.g., hospitalist, social worker) about the participant's risk of functional decline, ensuring that appropriate support and referrals are provided if needed.

Primary outcome measure

  • Client Satisfaction Questionnaire [ Time Frame: Endpoint (Day 30) ]
  • Perceived Characteristics of Intervention Scale [ Time Frame: Endpoint (Day 30) ]
  • Enrollment [ Time Frame: Baseline (Day 1) ]
  • Recruitment [ Time Frame: Baseline (Day 1) ]
  • Retention [ Time Frame: Endpoint (Day 30); 3-Month ]
  • Adherence [ Time Frame: Endpoint (Day 30); 3 Month ]
  • Fidelity [ Time Frame: Endpoint (Day 30) ]

Central Contacts and Locations

Central contacts

Caroline Madrigal, PhD

(401) 273-7100Caroline.Madrigal@va.gov

Jane Driver, MD

(857) 364-2560Jane.Driver@va.gov

Locations

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Caroline Madrigal, PhD

(401) 273-7100Caroline.Madrigal@va.gov

Jane Driver, MD

(857) 364-2560Jane.Driver@va.gov

Principal Investigator:

Caroline Madrigal, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Physical function
  • Transitional care
  • Function-focused care
  • Function
  • Care Transition
  • Physical performance
  • Functional performance
  • Health care transition
  • Transition of care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-24.