Use of an Electronic Diary by People With Multiple Sclerosis
Randomized Controlled Trial for the Evaluation of the Use of an Electronic Diary by People With Multiple Sclerosis
1 other identifier
interventional
100
1 country
1
Brief Summary
Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young adults, with onset usually at the age 20-40. Disease modifying therapies are available to MS, as well as drugs to improve patients' symptoms. Choosing the optimized treatment for each patient is a challenge to neurologists since predictive biomarkers for therapy are yet to be validated and approved. Current therapy decisions are based predominantly on clinical evaluation of disability and disease relapses. Adherence to treatment in MS is sub-optimal. Over the past few years a growing involvement of patients in their healthcare is noted, specially in chronic diseases, and Patient Reported Outcomes (PRO) are being incorporated as part of therapy evaluation. Several electronic patients diaries to track adherence to therapy, PRO and drugs side effects in diseases such as epilepsy are available. A mobile interactive patient diary (e-diary) tailored for persons with MS was developed. Users can enter data on drugs intake, drugs-side effects and disease symptoms and receive reminders regarding adherence to treatment. The aim of this study is to assess the benefits of the use of an e-diary for MS patients on healthcare. In order to achieve this goal, 80 MS patients will be randomized into two groups: a study group with access to the e-diary and a control group. After a period of one year, satisfaction with the e-diary will be assessed. The effect of the use of the e-diary on quality of life, on clinical outcomes and on adherence to therapy will be evaluated by comparing the two groups. This study will indicate the possible contribution of an e-diary for the evaluation of drugs safety and efficacy and of patient adherence to therapy, to be applied in clinical trials and towards improvement of MS patient' care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2013
CompletedFirst Posted
Study publicly available on registry
October 7, 2013
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 4, 2015
August 1, 2015
1.1 years
September 29, 2013
August 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Adherence to therapy
Adherence to therapy will be assessed through questionnaires on adherence in the study group and in the control group, at baseline and after one year.
one year
Study Arms (2)
e-diary
EXPERIMENTALThe study group will have assess to an e-diary developed for people with MS, through the Internet and/or smart-phones. In addition, participants will continue to receive regular care at the MS clinic
no use of e-diary
NO INTERVENTIONParticipants of the control group will receive regular care at the MS clinic and will and no use of the e-diary
Interventions
The e-diary can collect data on: * Medical data: information on diseases, treatments and attending physicians * Diary: daily report of drugs intake, symptoms and their intensity and additional relevant data * Reminders: the application can send reminders on drug intake or medical appointments to cellular phones or emails * Reports: textual and graphical reports of the data in the diary can be created
Eligibility Criteria
You may qualify if:
- MS patients visiting the MS clinic in the Carmel Medical Center, Haifa, Israel, that are currently receiving, or, are about to receive immunomodulatory treatment or/and receiving treatment for MS symptoms.
- Patients that browse in the Internet.
- Willing and able to give inform consent
- Age 18 to 70 years
You may not qualify if:
- Technical difficulties in the use of an e-diary
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carmel Medical Center
Haifa, 34362, Israel
Related Publications (1)
Le S, Shafer PO, Bartfeld E, Fisher RS. An online diary for tracking epilepsy. Epilepsy Behav. 2011 Dec;22(4):705-9. doi: 10.1016/j.yebeh.2011.08.035. Epub 2011 Oct 4.
PMID: 21975298BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ariel Miller, MD/PhD
Carmel Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2013
First Posted
October 7, 2013
Study Start
September 1, 2015
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
August 4, 2015
Record last verified: 2015-08