Health TrialsbyHealthPanel

The STRIVE Before Surgery Trial

ConditionsSurgery-ComplicationsDisability Physical
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

The STRIVE Before Surgery Trial evaluates patient-reported disability at 90 days after surgery following 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prehabilitation

    Behavioral

    The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.

Treatment groups

902 Participants
are divided into 2 treatment groups
Group A: PrehabilitationExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)

The WHODAS is a patient-reported disability scale that assesses limitations in six major life domains (i.e., cognition, mobility, self-care, social interaction, life activities, participation in society). Each questionnaire item is scored on a Likert scale ranging from 0 to 4. The sum of the responses is the WHODAS Disability Score (range: 0 to 48), which is expressed as a percentage of the maximum possible score

Time frame
3 months

Secondary outcomes

1

EuroQol Quality of Life Scale (EQ-5D-5L)

This is a well-validated instrument with Canadian valuation statistics and national implementation used to measure health-related quality of life after surgery and to inform incremental cost per quality-adjusted life year gained. Participants are asked to select one answer under each domain (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Responses range from having no problems with a particular domain to being unable to engage in that particular domain. Participants are asked to identify on a scale of 0-100 how good or bad their health is on that given day (0 being worst health they can imagine, 100 being best health they can imagine).

Time frame
1 month, 3 months, 1 year
2

A count of days at home in the 30-days after surgery

Count of days at home in the 30-days after surgery is a validated patient-centered outcome that can be ascertained from routinely collected data

Time frame
1 month
3

Survival

All cause deaths and survival time in the 30-days and year after surgery will be captured from vital statistics

Time frame
1 month, 1 year
4

Length of stay

Days from surgical admission to discharge will be calculated

Time frame
1 year

Other outcomes

Sponsors and contacts

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

Ottawa Hospital Research Institute

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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