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Use of an Electronic Diary by People With Multiple Sclerosis

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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
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center

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.


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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: e-diary
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
Device: e-diary

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

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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Technical difficulties in the use of an e-diary

Information from the National Library of Medicine

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


Contacts
Contact: Ariel Miller, MD/PhD 972-4-8250851 Ariel Miller <milleras@netvision.net.il>

Locations
Israel
Carmel Medical Center Not yet recruiting
Haifa, Israel, 34362
Principal Investigator: Ariel Miller, MD/PhD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Ariel Miller, MD/PhD Carmel Medical Center

Additional Information:
Publications:
Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01954823     History of Changes
Other Study ID Numbers: CMC-13-0065-CTIL
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: August 2015

Keywords provided by Carmel Medical Center:
Multiple sclerosis, Patient-reported outcomes, patient diary

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases