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Electronic Patient-reported Outcome Monitoring in Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria (ePRO-AA-PNH)

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ClinicalTrials.gov Identifier: NCT04128943
Recruitment Status : Completed
First Posted : October 16, 2019
Last Update Posted : October 5, 2020
Sponsor:
Collaborators:
ProPatient foundation of the University Hospital Basel
Novartis
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date October 15, 2019
First Posted Date October 16, 2019
Last Update Posted Date October 5, 2020
Actual Study Start Date November 1, 2019
Actual Primary Completion Date July 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2019)
  • recruitment with the ePRO application (number) [ Time Frame: Day 1= Day of inclusion ]
    Analyses of usability of the ePRO application by assessing recruitment with the ePRO application
  • usability of the ePRO application [ Time Frame: Weekly assessments from Day 1= Day of inclusion until Day 180 (+/- 7 days) = last day of testing phase ]
    Descriptive analyses of usability of the ePRO application by assessing data collection with the ePRO application
  • acceptability of the ePRO application [ Time Frame: Weekly assessments from Day 1= Day of inclusion until Day 180 (+/- 7 days) = last day of testing phase ]
    Descriptive analyses of acceptability of the ePRO application by assessing app utilization
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 16, 2019)
Change in quality of life assessed by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 questionnaire (EORTC QLQ-C30 questionnaire) [ Time Frame: at day 1= Day of inclusion and at day 180 (+/- 7 days) = last day of testing phase ]
Change in quality of life assessed by the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 incorporates nine multi-item scales: five functional scales (Physical, Role, Cognitive, Emotional and Social Functioning); three symptom scales (Fatigue, Pain and Nausea/Vomiting); and a Global Health Status/QoL scale. Six single item scales are also included (Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrhoea and Financial Difficulties). All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Original Secondary Outcome Measures
 (submitted: October 15, 2019)
Change in quality of life assessed by the EORTC QLQ-C30 questionnaire [ Time Frame: at day 1= Day of inclusion and at day 180 (+/- 7 days) = last day of testing phase ]
Change in quality of life assessed by the EORTC QLQ-C30 questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Electronic Patient-reported Outcome Monitoring in Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
Official Title Electronic Patient-reported Outcome Monitoring in Patients With Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria - a Pilot Study
Brief Summary Aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH) are interrelated and very rare diseases. Therefore, little data about clinical characteristics, especially the variety of symptoms in the course of the respective disease are available. As a consequence, patients may be left on their own between infrequent follow-ups at a specialist center. A web-based symptom-monitoring application can support selfmanagement and patient empowerment and promotes a patient- centered interdisciplinary team approach in the context of a "disease management program". This pilot study is to investigate usability and feasibility of the electronic Patient-Reported Outcome (ePRO) application in AA/PNH by assessing recruitment, app utilization, data collection, functionality, acceptability after using and working with the ePRO application.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All patients treated at the University Hospital Basel for AA and/or PNH
Condition
  • Aplastic Anemia
  • Paroxysmal Nocturnal Hemoglobinuria
Intervention
  • Other: symptom questionnaire

    A weekly filled in symptom questionnaire for reported symptoms of AA and/or PNH (yes/no, grade, date). Grading according to current grading systems (Common Terminology Criteria for Adverse Events,CTCAE).

    Data collection and processing via the ePRO application by Kaiku Health Ltd

  • Other: recording of vital signs
    Record function for vital parameters (blood pressure, temperature and pulse); Data collection and processing via the ePRO application by Kaiku Health Ltd
  • Other: European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 questionnaire
    The EORTC QLQ-C30 incorporates nine multi-item scales: five functional scales (Physical, Role, Cognitive, Emotional and Social Functioning); three symptom scales (Fatigue, Pain and Nausea/Vomiting); and a Global Health Status/QoL scale. Six single item scales are also included (Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrhoea and Financial Difficulties). All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
  • Other: interview
    Interview with the patients and responsible medical team by phone or during hospital visit about functional problems regarding the application (duration: 15-30 min) to avoid incorrect use of the application, at week 3 and month 3 and month 6
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 30, 2020)
9
Original Estimated Enrollment
 (submitted: October 15, 2019)
10
Actual Study Completion Date July 6, 2020
Actual Primary Completion Date July 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • AA (acquired and hereditary) and/or PNH patients
  • Minimal level of computer literacy with prior email experience and access to an Internet connection

Exclusion Criteria:

  • Mental alteration or psychiatric disease that can compromise written informed consent or adherence to the protocol and monitoring of the trial
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04128943
Other Study ID Numbers 2019-01563; me18Drexler
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor University Hospital, Basel, Switzerland
Collaborators
  • ProPatient foundation of the University Hospital Basel
  • Novartis
Investigators
Principal Investigator: Beatrice Drexler, Dr. med Division of Hematology, University Hospital Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date September 2020