CompletedNot Applicable

The STRIVE Before Surgery Pilot Trial

Canada144 participantsStarted 2024-01-30

Plain-language summary

The STRIVE Before Surgery Trial evaluates three pragmatic elements (recruitment, adherence, and follow-up) associated with participating in a home-based multimodal prehabilitation program supported through an online platform. Half of the participants will be randomized into the prehabilitation group, while the other half will be randomized into the control group.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥18 years
✓. Scheduled, or on the pathway, for inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery
✓. Expected surgery date between 3 and 12 weeks from enrollment
✓. Valid provincial health insurance number
✓. Access to internet-enabled device
✓. Email address

Exclusion criteria

✕. Inability to read and communicate in English
✕. Cognitive impairment preventing ability to provide informed consent independently
✕. No telephone/cell phone
✕. Cardiac, neurological or orthopedic procedure
✕. Surgery with no curative intent (palliative surgery)
✕. Patient not interested in participating in the context of their Telephone Assessment of Physical Activity (TAPA) score
✕. Any of the following cardiovascular conditions:
✕. Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea

What they're measuring

Monthly recruitment

Timeframe: 1 year

Intervention adherence

Timeframe: pre-surgery

Retention

Timeframe: 1 month, year 1

Elicitation of patient, clinician and researcher-identified barriers

Timeframe: 1 year

Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) (to be merged with larger trial)

Timeframe: 1 month, 3 month, 1 year

Trial details

NCT IDNCT06042491

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-04

View on ClinicalTrials.gov More Surgery-Complications trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥18 years
✓. Scheduled, or on the pathway, for inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery
✓. Expected surgery date between 3 and 12 weeks from enrollment
✓. Valid provincial health insurance number
✓. Access to internet-enabled device
✓. Email address

Exclusion criteria

✕. Inability to read and communicate in English
✕. Cognitive impairment preventing ability to provide informed consent independently
✕. No telephone/cell phone
✕. Cardiac, neurological or orthopedic procedure
✕. Surgery with no curative intent (palliative surgery)
✕. Patient not interested in participating in the context of their Telephone Assessment of Physical Activity (TAPA) score
✕. Any of the following cardiovascular conditions:
✕. Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea

What they're measuring

Monthly recruitment

Timeframe: 1 year

Intervention adherence

Timeframe: pre-surgery

Retention

Timeframe: 1 month, year 1

Elicitation of patient, clinician and researcher-identified barriers

Timeframe: 1 year

Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) (to be merged with larger trial)

Timeframe: 1 month, 3 month, 1 year