Use of an Electronic Diary by People With Multiple Sclerosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01954823|
Recruitment Status : Unknown
Verified August 2015 by Carmel Medical Center.
Recruitment status was: Not yet recruiting
First Posted : October 7, 2013
Last Update Posted : August 4, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Device: e-diary||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Controlled Trial for the Evaluation of the Use of an Electronic Diary by People With Multiple Sclerosis|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||December 2016|
The 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
The e-diary can collect data on:
No Intervention: no use of e-diary
Participants of the control group will receive regular care at the MS clinic and will and no use of the e-diary
- Change in Adherence to therapy [ Time Frame: one year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954823
|Contact: Ariel Miller, MD/PhD||972-4-8250851||Ariel Miller <firstname.lastname@example.org>|
|Carmel Medical Center||Not yet recruiting|
|Haifa, Israel, 34362|
|Principal Investigator: Ariel Miller, MD/PhD|
|Principal Investigator:||Ariel Miller, MD/PhD||Carmel Medical Center|