Functional ImpairmentCTraC-FITNCT07132944
Development and Feasibility of CTraC-FIT
A study testing CTraC-FIT in people with Functional Impairment and Functional Performance, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Functional Impairment, Functional Performance
- What is being tested?
- CTraC-FIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Score of > 3 on Vulnerable Elders Survey, (VES-13)
- Score of 4-9 on Short Physical Performance Battery (SPPB)
- Able to provide informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Caroline Madrigal, PhD, (401) 273-7100 ext. 16286, Caroline.Madrigal@va.gov
Jane Driver, MD, (857) 364-2560, Jane.Driver@va.gov
About this study
Official title: Development and Feasibility of a Function-focused Transitional Care Intervention to Support Functional Recovery in Older Veterans
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.
Read the detailed description
Nearly two-thirds of older adults experience significant functional decline after hospital discharge, resulting in loss of independence, institutionalization, and even death. Functional decline (i.e., loss of physical or cognitive ability that makes it difficult or impossible to perform activities of daily living) often occurs after hospital discharge due to a complex interplay between pre-existing health conditions, physiological stressors, and reduced mobility and activity levels during hospitalization. Veterans are at particular risk of functional decline as they experience a disproportionate burden of physical and psychological conditions compared to their non-Veteran peers. Transitions from hospital to home serve as critical junctures to address Veterans' functional needs, but many patients are discharged without a comprehensive functional evaluation. Even when evaluation occurs, discharge plans often fail to translate into effective care delivery, creating a concerning gap between planned and actual support after hospitalization.
The Coordinated Transitional Care (CTraC) program is a potential foundation on which to build a protocol that meets Veterans' rehabilitative care needs during and after discharge. CTraC is a nurse-led transitional care program developed to improve Veterans' transitions to the community after hospitalization. CTraC aims to address key components of transitional care: (1) care planning and communication; (2) medical follow-up; (3) education on symptom management; and (4) medication safety/management. In this model, the CTraC nurse identifies and meets Veterans at high risk of readmission, helps optimize their discharge planning, and then delivers a protocolized phone-based intervention for up to 30 days. CTraC has demonstrated significant benefits to VA, including a 50% reduction in readmissions, resolution of medication discrepancies for more than half of enrolled patients, and cost savings. Yet, the existing CTraC protocol misses a critical opportunity to include functional assessment and intervention to support Veterans' functional recovery.
The goal of this CDA-2 proposal is to develop and test a function-focused protocol for VA's CTraC program. The aim is to leverage CTraC's established success and infrastructure to comprehensively address Veterans' rehabilitation needs after hospitalization and optimize their functional recovery and independence during the transition from hospital to home. Specifically, this project aims to:
Aim 1: Develop \& refine CTraC-FIT (Functional Independence aT home) for Veterans at risk of functional decline transitioning from hospital to home. (1a) Develop CTraC-FIT to support Veterans' functional recovery based on input from clinicians (n=15) across hospital and outpatient settings (e.g., CTraC NCMs, inpatient providers, primary care providers, physical therapists, and occupational therapists). (1b) Conduct a nonrandomized, preliminary pilot of the CTraC-FIT intervention (n=5 Veterans) and collect qualitative feedback from Veterans and the CTraC NCM to refine the intervention protocol and study procedures, as well as address any unanticipated barriers before pilot testing.
Aim 2: Examine the feasibility and acceptability of CTraC-FIT in a pilot randomized controlled trial via randomization of n=40 Veterans to either CTraC-FIT (n=20) or an enhanced usual care condition (n=20). The primary outcomes will be feasibility and acceptability of the intervention protocol and study procedures. Feasibility and acceptability of the intervention protocol will be measured via survey and qualitative interviews with Veterans, and surveys with clinicians (n~20). Feasibility of the study procedures will be assessed via data logs (e.g., recruitment, enrollment, retention, adherence, randomization, and fidelity). Secondary outcomes will include Veterans' self-reported quality of life, social and cognitive function as well as self-reported and performance-based physical function measured at baseline, post-intervention, and 3-months post-intervention.]
- Conditions
- Functional Impairment, Functional Performance
- Being tested
- CTraC-FIT, Enhanced Usual Care
- Keywords
- Physical function, Transitional care, Function-focused care, Function, Care Transition, Physical performance, Functional performance, Health care transition, Transition of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTraC-FITOther
Also called Coordinated Transitional Care
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 CareOther
Also called EUC
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.
| Study group | Role | What they receive |
|---|---|---|
| CTraC-FIT | Experimental | 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. Receives: Other: CTraC-FIT |
| Enhanced Usual Care | Other | 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. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire
The investigators will measure Veteran satisfaction using the Client Satisfaction Questionnaire (CSQ-8), a validated tool that assesses satisfaction with various aspects of service delivery, including the quality of care, helpfulness of staff, and overall experience.
Measured: Endpoint (Day 30)
Perceived Characteristics of Intervention Scale
The investigators will use the Perceived Characteristics of Intervention Scale (PCIS) to understand clinicians' perspectives on the acceptability of the CTraC-FIT intervention. The PCIS is a validated tool designed to assess key factors influencing the acceptability of an intervention from the perspective of healthcare providers. Developed within VA, the scale assesses the overall acceptability of the intervention by examining whether it is perceived as beneficial, feasible, and compatible with existing practices.
Measured: Endpoint (Day 30)
Enrollment
Assessed by the proportion of those screened who enroll in the study, as well as the number of participants enrolled each month. This data will be sourced from the project database.
Measured: Baseline (Day 1)
Recruitment
Measured by the proportion of participants approached who agree to screening. This data will be sourced from the project database.
Measured: Baseline (Day 1)
Retention
Proportion of enrolled participants who complete the endpoint assessment and the 3-month follow-up. This data will be sourced from the project database.
Measured: Endpoint (Day 30); 3-Month
Adherence
The investigators will use a combination of metrics to determine adherence, including:
The proportion of completed phone or VVC (Video Visit Communication) calls The proportion of participants who establish functional goals The proportion of participants who achieve at least 50% of their goals The proportion of participants with a documented functional recovery care plan within 72 hours post-discharge This data will be sourced from the project database.
Measured: Endpoint (Day 30); 3 Month
Fidelity
Assessed by compliance with the CTraC-FIT fidelity checklist. This data will be sourced from the project database.
Measured: Endpoint (Day 30)
Secondary outcomes (3)
Performance-based Physical Function
The investigators will use the Short Physical Performance Battery (SPPB) to measure performance-based physical function over time. The SPPB's strong psychometric properties and ability to predict future disability and adverse events make it a valuable tool for evaluating the impact of the CTraC-FIT intervention on physical function and mobility.
Measured: Baseline (Day 1), Endpoint (Day 30), 3 Month
Self-reported Physical, Cognitive, and Social Function
The investigators will use the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 to measure physical, cognitive, and social function over the past 30 days, offering a comprehensive evaluation of function and disability. This self-report tool uses a 5-point Likert scale to assess difficulties in six domains: understanding and cognition, mobility, self-care, getting along, life activities, and participation.
Measured: Baseline (Day 1), Endpoint (Day 30), 3 Month
Quality of Life
The investigators will use the World Health Organization Quality of Life-BREF (WHOQOL-BREF) self-report instrument to assess and produce scores representative of quality of life in the domains of physical health, psychological health, social relationships, and environment in a 2-week timeframe. The WHOQOL-BREF's strong psychometric properties and comprehensive coverage of quality-of-life domains make it a valuable tool for understanding the potential impact of the CTraC-FIT intervention.
Measured: Baseline (Day 1), Endpoint (Day 30), 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Jul 2026
- Primary completion1 Oct 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ImpairmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility, acceptability, and preliminary effects of the CTraC-FIT protocol. Participants will be randomized into two groups: CTraC-FIT intervention and control group receiving enhanced usual care (EUC).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Caroline Madrigal, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132944
- Sponsor's protocol ID
- RRD9-002-24W
- Other IDs
- 1IK2RD000454-01A1
- Acronym
- CTraC-FIT
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility of a Function-focused Transitional Care Intervention to Support Functional Recovery in Older Veterans
- ClinicalTrials.gov ID
- NCT07132944
- Acronym / sponsor ID
- CTraC-FIT / RRD9-002-24W
- Conditions
- Functional Impairment, Functional Performance
- Keywords
- Physical function, Transitional care, Function-focused care, Function, Care Transition, Physical performance, Functional performance, Health care transition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nearly two-thirds of older adults experience significant functional decline after hospital discharge, resulting in loss of independence, institutionalization, and even death. Functional decline (i.e., loss of physical or cognitive ability that makes it difficult or impossible to perform activities of daily living) often occurs after hospital discharge due to a complex interplay between pre-existing health conditions, physiological stressors, and reduced mobility and activity levels during hospitalization. Veterans are at particular risk of functional decline as they experience a disproportionate burden of physical and psychological conditions compared to their non-Veteran peers. Transitions from hospital to home serve as critical junctures to address Veterans' functional needs, but many patients are discharged without a comprehensive functional evaluation. Even when evaluation occurs, discharge plans often fail to translate into effective care delivery, creating a concerning gap between planned and actual support after hospitalization.
The Coordinated Transitional Care (CTraC) program is a potential foundation on which to build a protocol that meets Veterans' rehabilitative care needs during and after discharge. CTraC is a nurse-led transitional care program developed to improve Veterans' transitions to the community after hospitalization. CTraC aims to address key components of transitional care: (1) care planning and communication; (2) medical follow-up; (3) education on symptom management; and (4) medication safety/management. In this model, the CTraC nurse identifies and meets Veterans at high risk of readmission, helps optimize their discharge planning, and then delivers a protocolized phone-based intervention for up to 30 days. CTraC has demonstrated significant benefits to VA, including a 50% reduction in readmissions, resolution of medication discrepancies for more than half of enrolled patients, and cost savings. Yet, the existing CTraC protocol misses a critical opportunity to include functional assessment and intervention to support Veterans' functional recovery.
The goal of this CDA-2 proposal is to develop and test a function-focused protocol for VA's CTraC program. The aim is to leverage CTraC's established success and infrastructure to comprehensively address Veterans' rehabilitation needs after hospitalization and optimize their functional recovery and independence during the transition from hospital to home. Specifically, this project aims to:
Aim 1: Develop \& refine CTraC-FIT (Functional Independence aT home) for Veterans at risk of functional decline transitioning from hospital to home. (1a) Develop CTraC-FIT to support Veterans' functional recovery based on input from clinicians (n=15) across hospital and outpatient settings (e.g., CTraC NCMs, inpatient providers, primary care providers, physical therapists, and occupational therapists). (1b) Conduct a nonrandomized, preliminary pilot of the CTraC-FIT intervention (n=5 Veterans) and collect qualitative feedback from Veterans and the CTraC NCM to refine the intervention protocol and study procedures, as well as address any unanticipated barriers before pilot testing.
Aim 2: Examine the feasibility and acceptability of CTraC-FIT in a pilot randomized controlled trial via randomization of n=40 Veterans to either CTraC-FIT (n=20) or an enhanced usual care condition (n=20). The primary outcomes will be feasibility and acceptability of the intervention protocol and study procedures. Feasibility and acceptability of the intervention protocol will be measured via survey and qualitative interviews with Veterans, and surveys with clinicians (n~20). Feasibility of the study procedures will be assessed via data logs (e.g., recruitment, enrollment, retention, adherence, randomization, and fidelity). Secondary outcomes will include Veterans' self-reported quality of life, social and cognitive function as well as self-reported and performance-based physical function measured at baseline, post-intervention, and 3-months post-intervention.]
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The investigators will conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility, acceptability, and preliminary effects of the CTraC-FIT protocol. Participants will be randomized into two groups: CTraC-FIT intervention and control group receiving enhanced usual care (EUC).
| Arm | Type | Receives |
|---|---|---|
| CTraC-FIT | Experimental | Other: CTraC-FITThe 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. |
| Enhanced Usual Care | Other | Other: Enhanced Usual CareThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Score of > 3 on Vulnerable Elders Survey, (VES-13)
- Score of 4-9 on Short Physical Performance Battery (SPPB)
- Able to provide informed consent
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTraC-FITAlso: Coordinated Transitional CareThe 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. | Other | CTraC-FIT |
| Enhanced Usual CareAlso: EUCThe 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. | Other | Enhanced Usual Care |
Primary outcome
Client Satisfaction Questionnaire
Time frame: Endpoint (Day 30)
The investigators will measure Veteran satisfaction using the Client Satisfaction Questionnaire (CSQ-8), a validated tool that assesses satisfaction with various aspects of service delivery, including the quality of care, helpfulness of staff, and overall experience.
Perceived Characteristics of Intervention Scale
Time frame: Endpoint (Day 30)
The investigators will use the Perceived Characteristics of Intervention Scale (PCIS) to understand clinicians' perspectives on the acceptability of the CTraC-FIT intervention. The PCIS is a validated tool designed to assess key factors influencing the acceptability of an intervention from the perspective of healthcare providers. Developed within VA, the scale assesses the overall acceptability of the intervention by examining whether it is perceived as beneficial, feasible, and compatible with existing practices.
Enrollment
Time frame: Baseline (Day 1)
Assessed by the proportion of those screened who enroll in the study, as well as the number of participants enrolled each month. This data will be sourced from the project database.
Recruitment
Time frame: Baseline (Day 1)
Measured by the proportion of participants approached who agree to screening. This data will be sourced from the project database.
Retention
Time frame: Endpoint (Day 30); 3-Month
Proportion of enrolled participants who complete the endpoint assessment and the 3-month follow-up. This data will be sourced from the project database.
Adherence
Time frame: Endpoint (Day 30); 3 Month
The investigators will use a combination of metrics to determine adherence, including: The proportion of completed phone or VVC (Video Visit Communication) calls The proportion of participants who establish functional goals The proportion of participants who achieve at least 50% of their goals The proportion of participants with a documented functional recovery care plan within 72 hours post-discharge This data will be sourced from the project database.
Fidelity
Time frame: Endpoint (Day 30)
Assessed by compliance with the CTraC-FIT fidelity checklist. This data will be sourced from the project database.
3 secondary outcomes
Performance-based Physical Function
Time frame: Baseline (Day 1), Endpoint (Day 30), 3 Month
Self-reported Physical, Cognitive, and Social Function
Time frame: Baseline (Day 1), Endpoint (Day 30), 3 Month
Quality of Life
Time frame: Baseline (Day 1), Endpoint (Day 30), 3 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline Madrigal, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTraC-FIT in people with Functional Impairment and Functional Performance, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Madrigal, PhD ((401) 273-7100 ext. 16286, Caroline.Madrigal@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire (time frame: Endpoint (Day 30)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.