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Profile of Adherence to Therapy and Interventions to Promote Adherence in MS

NCT02488343 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2022-08-02

No results posted yet for this study

Summary

Adherence is an active process wherein the patient acts in collaboration with the medical and paramedical staff in order to improve his/her health. Adherence to medication comprises of implementation and persistence and it is estimated to be around 50% in various chronic illnesses, including Multiple Sclerosis (MS). MS patients who fail to properly adhere to their DMTs regimen may be at increased risk for the development of new central nervous system lesions, exacerbations, increased disabilities and poorer quality of life. Plausible reasons for the low adherence rates in MS mentioned in the literature include patients' attributes, condition attributes and therapy related factors.

The objective of this study is to develop a personal profile of adherence based in the factors mentioned above. In the first part of the study patients will be followed up and the profile My Multiple Sclerosis Perception Adherence Scoring System (MyMS\_PASS) will be created and tested. In the second part, patients with non-optimal rates of adherence will receive tailored intervention in order to improve therapy to treatment. This work may serve as a model for the study of adherence to therapy and the development of interventions in MS as well as in other chronic diseases.

Conditions

Interventions

BEHAVIORAL

Behavioral Intervention

Three types of intervention will be used: a) Interventions aimed to dealing with cognitions and habits will be based on cognitive-behavioral therapy (CBT) principles. b) Interventions aimed to dealing with affective factors that interfere with adherence will be based on dynamic therapy, crisis intervention and supportive elements. c) In the case of condition-related or therapy related barriers to adherence, psycho-educational multidisciplinary interventions of 1-2 appointments will be offered. Education about injection techniques and about reasonable expectations from therapy, and from MS itself, are a key strategy to successfully maintaining adherence.

Sponsors & Collaborators

  • Carmel Medical Center

    lead OTHER

Principal Investigators

  • Ariel Miller, MD, PhD · Technion, Israel Institute of Technology, and Carmel Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02488343 on ClinicalTrials.gov