Profile of Adherence to Therapy and Interventions to Promote Adherence in MS
Personal Profile of Adherence to Therapy and Tailored Interventions to Promote Adherence in Multiple Sclerosis Patients
1 other identifier
interventional
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Aug 2015
Longer than P75 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedAugust 2, 2022
July 1, 2022
8.8 years
June 28, 2015
July 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adherence to therapy by assessment of remaining pills/medication claims electronic records
For oral therapy: Adherence to therapy as indicated by the number of pills remaining in the pills empty packages
24 months
Adherence to therapy according to ProMas
Improvement in therapy adherence as measured by Probabilistic Medication Adherence Scale (ProMas). Adherence categories are low (sum score 0-4), medium low (sum score 5-9), medium-high (sum score 10-14) and high (sum score 15-18)
24 months
Adherence to therapy according to MS-TAQ
Improvement in therapy adherence as measured by Multiple Sclerosis Treatment Adherence Questionnaire (MSTEQ). The items from MS-TAQ used in this analysis tapped whether the participant did not take a prescribed dose in the last four weeks and the reported number of these doses. In cases of reported non-adherence, the percentage was calculated per regiment.
24 months
Secondary Outcomes (1)
Improvement in quality of life
24 months
Study Arms (2)
Behavioral Intervention
EXPERIMENTALParticipants in this group will receive tailored psychological intervention to promote adherence to their drug therapy.
Non Intervention group
NO INTERVENTIONParticipants in this group will be observed but will not receive any intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- MS patients according to Poser diagnosis
- treated or planned to be treated with Disease Modifying Therapies
- age 18 to 70
- signed informed consent
- both male and female
You may not qualify if:
- pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MS Clinic, Carmel Medical Center
Haifa, Israel
Related Publications (1)
Neter E, Glass-Marmor L, Wolkowitz A, Lavi I, Miller A. Beliefs about medication as predictors of medication adherence in a prospective cohort study among persons with multiple sclerosis. BMC Neurol. 2021 Mar 25;21(1):136. doi: 10.1186/s12883-021-02149-0.
PMID: 33761887DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ariel Miller, MD, PhD
Technion, Israel Institute of Technology, and Carmel Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Multiple Sclerosis & Brain Research Center, Carmel Medical Center
Study Record Dates
First Submitted
June 28, 2015
First Posted
July 2, 2015
Study Start
August 1, 2015
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
August 2, 2022
Record last verified: 2022-07