Randomized Controlled Trial for the Evaluation of the Use of an Electronic Diary by People With Multiple Sclerosis

Status unknownNot a drug-phase studyMS (type not specified)NCT01954823

What it found

No results 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

Loading reviews and guidelines…

History

    1. Started

      Sept 2015

    2. Main results due

      Oct 2016

    3. Finished

      Dec 2016

    Assembled by software from public sources.