Aortic Aneurysm
Conditions
Keywords
Aortic aneurysm, Prehabilitation, Collaborative care
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.
Detailed description
This is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the Ready for Recovery program. 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 primary outcome is feasibility (measured by percentage of phone 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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
* Cognitive disturbance * Current pregnancy or plan to become pregnant prior to surgery * Inability to write/speak fluently in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention feasibility | Weekly over 6 weeks | Percentage of intervention phone sessions completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Proportion of assessment sessions in which outcome data is obtained from participants and the medical record |
| Utility of the Ready for Recovery program | 6 weeks | Participants will rate the utility of the 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 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 | Physical function will be measured using the 20-item PROMIS Physical Function Scale (PROMIS PF-20). PROMIS PF-20 scores range from 20 to 100, with higher scores indicating higher levels of physical function. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristopher M Celano, M.D.
Massachusetts General Hospital
Outcome results
None listed