Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05348252
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2022-04-05
Brief Title:
Patient Journey Application for Discontinuing Inappropriate PPI Use a Randomized Controlled Trial
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Patient Journey Application for Discontinuing Inappropriate PPI Use a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPPORT
Brief Summary:
Rationaleobjective This study hypothesizes that offering patient-tailored and dosed information on PPI discontinuation in patients with inappropriate chronic PPI use will result in an increased discontinuation rate when compared to a conventional information folder offering all information on discontinuing inappropriate PPI use at once
Study design Multicenter randomized controlled trial
Study population A minimum 152 patients with chronic PPI use without a valid indication for chronic PPI use according to the NHG-guidelines will be included Possible participants will be identified at the outpatient clinics of the departments of Internal Medicine Gastroenterology Rheumatology and Nephrology in the Radboud University Medical Center Canisius Wilhelmina Hospital and Sint Maartenskliniek
Intervention Timely informing patients on discontinuing PPI use through the Patient Journey App
Control Conventional information consisting of an online information folder on discontinuing PPI use
Inclusion criteria
Patients with daily PPI use for at least 4 weeks
Age 18-70 years
Exclusion criteria
Chronic PPI indication according to NHG-guidelines
Chronic PPI indication according to treating physician despite absence of chronic PPI indication according to NHG-guidelines
Patients that underwent anti-reflux surgery
No understanding of the study or study procedures including the digital application smartphonecomputer skills
No smartphonecomputer available
No informed consent
Limited life span
Primary end point
- Discontinuation of PPI use at 2-month follow-up defined as self-declared intake of a maximum of 1 tablet in the previous 14 days
Secondary end points
Upper gastrointestinal symptoms or disorders that are potentially related to discontinuation of PPI use subdivided as
Upper gastrointestinal symptoms as measured by the Patient Assessment of Gastrointestinal Symptom Severity Score PAGI-SYM
Any upper gastrointestinal event that requires a doctors visit or hospitalization
Potential adverse drug reactions ADRs of PPIs subdivided as
Most prevalent 1-10 ADRs according to the Medicines Evaluation Board1 obstipation diarrhea meteorism abdominal pain nauseavomitus headache
Other potential ADRs requiring a doctors visit or hospitalization The following disorders are considered as potentially related to PPI use any pneumonia gastroenteritis vitamin B12 deficiency iron deficiency calcium deficiency fractures acute interstitial nephritis or hypomagnesaemia
Frequency of PPI use measured monthly during follow-up measured as number of PPI tablets per month
Start of new medication for upper gastrointestinal symptoms other than PPI eg antacids H2-blockers analgesics anti-emetics
Association between successful discontinuation and variables such as gender age fear of ADRs occurrence of potential ADRs or occurrence of rebound effect
Change in lifestyle BMI smoking status and alcohol usage
Patient Journey App usability as measured by the System Usability Score SUS
Self-management behavior as measured by the short Patient Activation Measure PAM-13
Recurrent PPI use defined as the intake of more than 1 PPI tablet in the previous 14 days measured as self-declared intake during follow-up after successful discontinuation during follow-up
Study design Multicenter randomized controlled trial
Study population A minimum 152 patients with chronic PPI use without a valid indication for chronic PPI use according to the NHG-guidelines will be included Possible participants will be identified at the outpatient clinics of the departments of Internal Medicine Gastroenterology Rheumatology and Nephrology in the Radboud University Medical Center Canisius Wilhelmina Hospital and Sint Maartenskliniek
Intervention Timely informing patients on discontinuing PPI use through the Patient Journey App
Control Conventional information consisting of an online information folder on discontinuing PPI use
Inclusion criteria
Patients with daily PPI use for at least 4 weeks
Age 18-70 years
Exclusion criteria
Chronic PPI indication according to NHG-guidelines
Chronic PPI indication according to treating physician despite absence of chronic PPI indication according to NHG-guidelines
Patients that underwent anti-reflux surgery
No understanding of the study or study procedures including the digital application smartphonecomputer skills
No smartphonecomputer available
No informed consent
Limited life span
Primary end point
- Discontinuation of PPI use at 2-month follow-up defined as self-declared intake of a maximum of 1 tablet in the previous 14 days
Secondary end points
Upper gastrointestinal symptoms or disorders that are potentially related to discontinuation of PPI use subdivided as
Upper gastrointestinal symptoms as measured by the Patient Assessment of Gastrointestinal Symptom Severity Score PAGI-SYM
Any upper gastrointestinal event that requires a doctors visit or hospitalization
Potential adverse drug reactions ADRs of PPIs subdivided as
Most prevalent 1-10 ADRs according to the Medicines Evaluation Board1 obstipation diarrhea meteorism abdominal pain nauseavomitus headache
Other potential ADRs requiring a doctors visit or hospitalization The following disorders are considered as potentially related to PPI use any pneumonia gastroenteritis vitamin B12 deficiency iron deficiency calcium deficiency fractures acute interstitial nephritis or hypomagnesaemia
Frequency of PPI use measured monthly during follow-up measured as number of PPI tablets per month
Start of new medication for upper gastrointestinal symptoms other than PPI eg antacids H2-blockers analgesics anti-emetics
Association between successful discontinuation and variables such as gender age fear of ADRs occurrence of potential ADRs or occurrence of rebound effect
Change in lifestyle BMI smoking status and alcohol usage
Patient Journey App usability as measured by the System Usability Score SUS
Self-management behavior as measured by the short Patient Activation Measure PAM-13
Recurrent PPI use defined as the intake of more than 1 PPI tablet in the previous 14 days measured as self-declared intake during follow-up after successful discontinuation during follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None