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
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- e-diary
What it measured
Main measures
Change in Adherence to therapy
one year
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 70
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Sept 2015
Main results due
Oct 2016
Finished
Dec 2016