An interventional study of Ready for Recovery and Enhanced Ready for Recovery in Aortic Aneurysm, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
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.
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.
222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.
This study's planned enrollment of 45 is below the median of 62 across 101 interventional studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Exclusion Criteria:
Participants in this arm will receive the 6-week Ready for Recovery intervention prior to surgery.
Behavioral: Ready for Recovery
Participants in this arm will receive the 6-week Ready for Recovery intervention prior to surgery, plus an additional 4-week intervention post-surgery.
Behavioral: Enhanced Ready for Recovery
Participants in this arm will receive standard medical care and no additional interventions.
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.
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.
Intervention feasibility
Percentage of intervention phone sessions completed
Time frame: Weekly over 6 weeks (Ready for Recovery group) or 10 weeks (Enhanced Ready for Recovery group)
Intervention Utility
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.
Time frame: 6 weeks (Ready for Recovery) or 10 weeks (Enhanced Ready for Recovery)
Change in functional capacity (1 Minute Sit to Stand Test)
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.
Time frame: Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge
Change in physical function (PROMIS PF-20)
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.
Time frame: Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge
Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)
The SF-12 physical component score will be used to assess physical health-related quality of life (Range: 0-100). Higher scores indicate higher levels of physical health-related quality of life.
Time frame: Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge
Change in mental health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] mental component score)
The SF-12 mental component score will be used to assess mental health-related quality of life (Range: 0-100). Higher scores indicate higher levels of mental health-related quality of life.
Time frame: 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])
Depressive symptoms will be measured using the 9-item Patient Health Questionnaire (PHQ-9). The PHQ-9 ranges from 0-27, with higher scores indicating higher levels of depression.
Time frame: Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge
Change in anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7])
Anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). The GAD-7 ranges from 0-21, with higher scores indicating higher levels of anxiety
Time frame: Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge
Change in perceived stress (Perceived Stress Scale)
Perceived stress will be assessed via the Perceived Stress Scale (PSS). PSS scores range from 0-40, with higher scores indicating higher levels of perceived stress.
Time frame: Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge
Change in cognition (telephonic Montreal Cognitive Assessment [t-MoCA])
Cognition will be measured using the telphonic Montreal Cognitive Assessment (t-MoCA). t-MoCA scores range from 0 to 22, with higher scores indicating better cognition.
Time frame: Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge
Change in perceived social support (Multidimensional Scale of Perceived Social Support)
Perceived social support will be measured by the Multidimensional Scale of Perceived Social Support (MSPSS). MSPSS scores range from 1-7, with higher scores indicating higher levels of perceived social support.
Time frame: Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge
Change in self-reported physical activity (International Physical Activity Questionnaire [IPAQ]; in metabolic equivalent-minutes/week)
This will be measured via the International Physical Activity Questionnaire (IPAQ) as a secondary measure of physical activity.
Time frame: Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge
Changes in cigarette smoking (in number of cigarettes smoked per week)
Participants will be asked how many cigarettes they have smoked in the past week.
Time frame: Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge
Incidence of postoperative complications
We will review participant records to identify cardiac, pulmonary, renal, and cognitive complications that occur during the post-operative hospital stay.
Time frame: Perioperative/periprocedural
Delirium incidence
Delirium incidence will be assessed through review of the electronic health record using a validated tool designed for this purpose. It will be identified through a diagnosis of delirium, use of medications (e.g., antipsychotic medications) for the management of agitation, or mentions of confusion, disorientation, or agitation in nursing notes.
Time frame: Perioperative/periprocedural
Intensive Care Unit (ICU) length of stay
We will measure the amount of time the participant spends in the ICU following the surgical procedure.
Time frame: Perioperative/periprocedural
Hospital length of stay
We will measure the amount of time the participant spends hospitalized for aortic aneurysm repair.
Time frame: Perioperative/periprocedural
Incidence of hospital readmissions
We will measure the incidence and time of hospital readmissions following discharge after the surgical procedure.
Time frame: 30 days post-discharge, 90 days post-discharge
Mortality
We will measure the incidence and timing of mortality, based on electronic health record review.
Time frame: 30 days post-discharge, 90 days post-discharge.
Plan to share: No
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