Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06065995
Other study ID # 2022.0505
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2022
Est. completion date December 31, 2025

Study information

Verified date October 2023
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Miguel Overzier, BSc
Phone 0205663370
Email m.m.overzier@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to investigate if access to the StoMakker application will significantly improve health-related quality of life in children receiving surgery resulting in an ileostomy, colostomy or continent urostomy. The main question it aims to answer are: - Does access to StoMakker improve health-related quality of life in children receiving surgery for an ostomy? - Does access to StoMakker improve the anxiety and social functioning of children receiving surgery for an ostomy? - Does access to StoMakker improve postoperative complications of children receiving surgery for an ostomy? Participants will be asked to fill in several questionnaires around their surgery. The intervention group of the trial will be given access to the application "StoMakker". The control group of the trial will receive standard care.


Description:

Peer support, patient education and -guidance are of crucial importance for children undergoing surgery for a stoma. Current supportive care is either lacking or via paper folders, which is not a suitable strategy for supporting this vulnerable group of children. The main objective of this prospective trial is to investigate whether access to a peer support platform, age-dependent information provision and games using a smartphone application increases self-reported health related quality of life (HRQOL). Study population: Children aged between 6 and 18 years old who will receive an ileostomy, colostomy or continent urostomy, are eligible for inclusion. Participants must have access to a smartphone or tablet. Children who are unable to use a smartphone due to mental or physical disabilities will be excluded from the study Patients and their parents/caregivers are obliged to give written informed consent before they are allowed to be enrolled in the study. The design of the study is an open-label multicenter randomized controlled trial with a follow-up of 6 months. The intervention group will get access to the app. The control group will receive standard care. Measurement is done via questionnaires, which are send at specificic intervals based on the surgery date. Parents or caregivers will also receive several questionnaires at specific intervals based on the surgery date. The primary outcome of this study is health-related quality of life. Secondary outcomes are postoperative outcomes, knowledge retention, patient satisfaction with the received care and self-efficacy


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - Individuals scheduled for ileostomy, colostomy or continent urostomy surgery - Children aged between 6 and 18 years - Possession of, or continous access to a smartphone or tablet operated with iOS 9 and up or Android 8.0 and up - Access to email and internet Exclusion Criteria: - Incompetence of understanding the Dutch language - Visual impairment, unless well corrected with visual aids - Physical disabilities limiting the use of a mobile application - Mental disabilities limiting the use of a mobile application, learning and filling in questionnaires - Patients with pre-existing skin conditions such as pemphigus, para-pemphigus or psoriasis that may disturb or influence normal stoma care protocols

Study Design


Intervention

Device:
StoMakker
A mobile application that offers age dependent information, a peer support platform and a game

Locations

Country Name City State
Netherlands Academic Medical Centre Amsterdam-Zuidoost Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in health-related quality of life of participants on the age specific 7 item PROMIS Pediatric Global Health scale (PGH-7) questionnaire at 6 months after surgery The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health scale (PGH-7) is a validated self reported instrument for assessing general health. Scores range from 5 (low health-related quality of life) to 35 (high health-related quality of life). The questionnaire has been translated to dutch and validated in the Netherlands and dutch speaking Belgium
Change = 6 month score - baseline
6 months follow-up
Secondary Change from baseline in anxiety of participants on the age specific 8 item PROMIS pediatric v2.0 Anxiety and Depressive Symptoms, the short form 8a questionnaire at 6 months follow-up The Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric item banks v2.0 Anxiety and Depressive Symptoms, the short forms 8a is a validated questionnaire. Scores range from 8 to 40 where a higher score indicates a higher level of anxiety
The questionnaire has been translated to dutch and validated in the Netherlands and dutch speaking Belgium
Change = 6 month score - baseline
6 months follow-up
Secondary Change from baseline in social functioning of participants on the age specific PROMIS pediatric item bank peer relationships short form 8a at 6 months after surgery The Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric item banks v2.0 Peer relationships, the short forms 8a is a validated questionnaire. Scores range from 8 to 40 where a higher score indicates a higher level of social functioning
The questionnaire has been translated to dutch and validated in the Netherlands and dutch speaking Belgium
Change = 6 month score - baseline . Scores range from 8 (low social functioning) to 40 (high social functioning)
6 months follow-up
Secondary Occurrence of any surgery related complications as specified by the clavien-dindo classification within 6 months of follow-up. The Clavien Dindo Classification is used to rank the severity of a surgical complication. It is based on the type of therapy needed to correct the complication. The scale consists of several grades (Grade I, II, IIIa, IIIb, IVa, IVb and V). Grade I complications are usually mild but Grade II and higher complications are more significant. Examples include (but are not limited to): infections requiring antibiotics, blood transfusions or injury to abdominal or pelvic structures 6 months follow up
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04046913 - The ADDapt Diet in Reducing Crohn's Disease Inflammation N/A
Active, not recruiting NCT04989907 - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Active, not recruiting NCT04990258 - A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
Completed NCT06216223 - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients N/A
Enrolling by invitation NCT06015789 - Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Recruiting NCT03282786 - Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT04960826 - Study of an Environmental Risk Factor in Crohn's Disease
Recruiting NCT05413941 - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease N/A
Completed NCT03668249 - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed NCT00721812 - A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 Phase 1
Recruiting NCT05809999 - IBD Neoplasia Surveillance RCT N/A
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Recruiting NCT04991324 - Cholecalciferol Comedication in IBD - the 5C-study Phase 3
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Not yet recruiting NCT05043818 - A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A
Completed NCT02874365 - Intestinal Stem Cells Characterization N/A