Aortic Aneurysm
Conditions
Brief summary
This is a three-arm, randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of two multicomponent interventions to promote recovery from aortic aneurysm repair procedures.
Detailed description
This is a three-arm, randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of two multicomponent programs (Ready for Recovery and an enhanced version of the program) to prepare patients for aortic aneurysm repair and to promote their recovery. Ready for Recovery is a 6-week collaborative care program to prepare individuals for surgical procedures to repair an aortic aneurysm. Participants will speak with a study trainer on the phone each week and will set goals related to physical activity, a healthy diet, and inspiratory muscle training. They also will be given resources to reduce stress, treat anxiety and depression (if present), and stop smoking, and the study team will make recommendations regarding medication adjustments to reduce complications after surgery. The enhanced version has an additional four weeks of phone sessions post-surgery, to provide support and guidance during the early recovery period. The control condition will be standard medical care. The primary outcome is feasibility (measured by proportion of sessions completed). Secondary outcomes include acceptability (measured by weekly 0-10 utility ratings) and preliminary impact on functional, psychological, and health behavior outcomes.
Interventions
BEHAVIORALReady for Recovery
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.
BEHAVIORALEnhanced Ready for Recovery
The enhanced Ready for Recovery program is a 10-week, multicomponent, tailored, prehabilitation intervention to promote recovery from aortic aneurysm repair. 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. Following surgery, participants will engage in four additional weekly sessions to discuss the recovery process and plan for longer-term behavior change.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Three-arm, randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults undergoing elective aortic aneurysm repair (open or endovascular)
Exclusion criteria
* Emergent aortic aneurysm repair * Cognitive disturbance * Functional impairment significantly impacting the ability to stand or walk * Current pregnancy or plan to become pregnant prior to surgery * Inability to write/speak fluently in English * Lack of access to a phone, computer, or tablet with internet access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention feasibility | Weekly over 6 weeks (Ready for Recovery group) or 10 weeks (Enhanced Ready for Recovery group) | Percentage of intervention phone sessions completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Utility | 6 weeks (Ready for Recovery) or 10 weeks (Enhanced Ready for Recovery) | Participants will rate the utility of the Ready for Recovery program or enhanced Ready for Recovery program on an 11-point Likert scale (0-10), with 0 being not at all helpful and 10 being very helpful. |
| Change in functional capacity (1 Minute Sit to Stand Test) | Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge | Functional capacity will be measured using the 1-minute Sit to Stand Test. Participants will be instructed to stand up and sit back down on an armless chair repeatedly for one minute as quickly as possible. The number of times the participant fully stands and then sits down again will be recorded. |
Countries
United States
Contacts
CONTACTChristopher M Celano, M.D.
PRINCIPAL_INVESTIGATORChristopher M Celano, M.D.
Massachusetts General Hospital
Outcome results
None listed