Impact Study of a Digital Solution for Patient Engagement

NCT04153721 | Completed

• 1 other identifier: 19-007
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative). Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes. Medtronic has designed an digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery. The IHU is a pilot experiment site for this solution. This research protocol, of which the IHU is the promoter, aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital. The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices. The solution is not a medical device. It is limited to advice, monitoring and restitution of data declared by the patient; it is not intended to prevent, diagnose or treat the pathology; it is independent of any other medical device. This study aims to assess the pre-operative impact of the solution, in terms of patients' adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery. The secondary purpose of the study is to precise the acceptability of the solution.

Conditions

Colorectal Cancer

Keywords

enhanced recovery; rehabilitation; prehabilitation; patient engagement; digital health; e-health; colorectal surgery; preparation; follow-up; patient empowerment

Outcome Measures

Primary Outcomes (4)

• Evaluation, during the preoperative phase, of patients' compliance to the program, assessed by a completeness rate.

  Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The first part of the primary endpoint of the study is the average rate of completeness of the preoperative program: percentage based on the status (done / not done) of pre-operative tasks specific to each patient

  From the inclusion to the surgery

• Change, during the preoperative phase, of the physical condition of the patients, assessed by 6MTW scoring.

  Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The second part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the physical condition : comparison between two walk tests, one done at the inclusion, the other when admitted for surgery. The result of the walk test is the distance travelled in meters during the test (6 minutes) by the patient.

  At the start of the program (6 weeks before the surgery) and at the admission before the surgery

• Change, during the preoperative phase, of the psychological condition of the patients, assessed by the PHQ8 questionnaire scoring.

  Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The third part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the psychological condition assessed by the questionnaire PHQ8 (Brief "Patient Health Questionnaire" depression scale): questions the existence and intensity of depressive symptoms (score from 0 to 24 in case of severe depression).

  At the start of the program (6 weeks before the surgery) and at the admission before the surgery

• Change, during the preoperative phase, of the psychological condition of the patients, assessed by GAD7 questionnaire scoring.

  Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The fourth part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the psychological condition evaluated by the questionnaire GAD7 ("Generalized Anxiety Disorder 7"-item): indicates the severity of the anxiety (score from 0 to 21 in case of generalized anxiety disorder)

  At the start of the program (6 weeks before the surgery) and at the admission before the surgery

Secondary Outcomes (10)

• Evaluation of patients' compliance with their post-operative program

  Everyday for 7 days after the discharge from hospital and on the 14th day after the discharge from hospital

• Persistence of program compliance between pre- and post-operative phases

  From the inclusion to the end of participation

• Patient satisfaction regarding the program

  2 days before the surgery and on the 14th day after the discharge from hospital

• Evaluation, during the preoperative phase, of patient use of the program without compliance, assessed by a rate of undone activities

  from 6 weeks before the surgery up to the surgery

• Patient interactions with the help desk of the solution

  from the inclusion to the end of participation

Study Arms (1)

Digital Solution

EXPERIMENTAL

The proposed digital solution aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices

Behavioral: Name Digital Solution

Interventions

Name Digital Solution BEHAVIORAL

The digital solution offers a pre-operative program of information (pathology, treatment modalities, protocols to be followed) and training (stress management, psychological support, optional: nutritional preparation, physical exercise, reduction of alcohol and tobacco consumption). In the post-operative phase, patients must daily assess their state of health (temperature, weight, wound, nausea / vomiting, urine / stool) and well-being (physical, moral, sleep, pain), from day 1 to day 7 after discharge, to facilitate the detection of complications by the medical team

Digital Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major patient candidate for a scheduled colorectal surgery and whose admission is expected within 8 days minimum
• Patient with an email address and an internet connection
• Patient able to receive and understand information about the study and give written informed consent

You may not qualify if:

• Patient under the age of 18 years old.
• Pregnant or lactating patient
• Patient under guardianship, trusteeship or the protection of justice

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, 67000, France

Location

Related Publications (17)

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Related Links

• French National Authority for Health, Recommendation of good practice: Adult characterized depressive episode : primary care. October 2017

MeSH Terms

Conditions

Colorectal Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Didier Mutter, MD, PhD

  Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: November 6, 2019
• Study Start: March 11, 2020
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)