NCT06998498

Brief Summary

This is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the Ready for Recovery program, a 6-week collaborative care intervention to help prepare individuals for repair of aortic aneurysms.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

October 8, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

6 months

First QC Date

May 22, 2025

Last Update Submit

October 28, 2025

Conditions

Aortic Aneurysm

Keywords

Aortic aneurysmPrehabilitationCollaborative care

Outcome Measures

Primary Outcomes (1)

  • Intervention feasibility

    Percentage of intervention phone sessions completed

    Weekly over 6 weeks

Secondary Outcomes (3)

  • Feasibility of data collection

    Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

  • Utility of the Ready for Recovery program

    6 weeks

  • Change in physical function (PROMIS PF-20)

    Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

Other Outcomes (9)

  • Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)

    Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

  • Change in mental health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] mental component score)

    Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

  • Change in depressive symptoms (9-item Patient Health Questionnaire [PHQ-9])

    Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

  • +6 more other outcomes

Study Arms (1)

Ready for Recovery

EXPERIMENTAL

Participants in this arm will receive the Ready for Recovery intervention.

Behavioral: Ready for Recovery

Interventions

Ready for RecoveryBEHAVIORAL

The Ready for Recovery program is a 6-week, multicomponent, tailored, prehabilitation intervention to promote the optimization of medical and psychological status prior to surgery. Its key components include education, enhancement of beneficial health behaviors, reduction of negative psychological symptoms, and the promotion of social support. Following an initial session, the team will develop a customized prehabilitation plan for each participant. Participants will work towards goals each week and will discuss progress with their study trainer via weekly phone sessions, which will continue until the scheduled surgical procedure.

Ready for Recovery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults undergoing elective aortic aneurysm repair (open or endovascular)

You may not qualify if:

  • Cognitive disturbance
  • Current pregnancy or plan to become pregnant prior to surgery
  • Inability to write/speak fluently in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02155, United States

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Christopher M Celano, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher M Celano, M.D.

CONTACT

617-726-6485ccelano@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, Cardiac Psychiatry Research Program

Study Record Dates

First Submitted

May 22, 2025

First Posted

May 31, 2025

Study Start

October 8, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

October 30, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)