Health TrialsbyHealthPanel

Ready for Recovery Pilot Trial

ConditionAortic Aneurysm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults undergoing elective aortic aneurysm repair (open or endovascular)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ready for Recovery

    Behavioral

    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.

  • Enhanced Ready for Recovery

    Behavioral

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Ready for RecoveryExperimental treatment 1 intervention
Group B: Enhanced Ready for RecoveryExperimental treatment 1 intervention
Group C: Standard Medical CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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

Other outcomes

1

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
2

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
3

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
4

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: