Profile of Adherence to Therapy and Interventions to Promote Adherence in MS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02488343|
Recruitment Status : Recruiting
First Posted : July 2, 2015
Last Update Posted : August 9, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Behavioral Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Personal Profile of Adherence to Therapy and Tailored Interventions to Promote Adherence in Multiple Sclerosis Patients|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Behavioral Intervention
Participants in this group will receive tailored psychological intervention to promote adherence to their drug therapy.
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.
No Intervention: Non Intervention group
Participants in this group will be observed but will not receive any intervention.
- Adherence to therapy by assessment of remaining pills/medication claims electronic records [ Time Frame: 24 months ]For oral therapy: Adherence to therapy as indicated by the number of pills remaining in the pills empty packages
- Adherence to therapy according to ProMas [ Time Frame: 24 months ]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)
- Adherence to therapy according to MS-TAQ [ Time Frame: 24 months ]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.
- Improvement in quality of life [ Time Frame: 24 months ]Improvement in quality of life as measured by the World Health Organization Quality of Life-Bref instrument (WHOQOL-Bref)
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): NCT02488343
|Contact: Ariel Miller, MD, PhDfirstname.lastname@example.org|
|MS Clinic, Carmel Medical Center||Recruiting|
|Contact: Ariel Miller, MD PhD 972-4-8250851 Ariel_Miller@clalit.org.il|
|Principal Investigator: Ariel Miller, MD PhD|
|Principal Investigator:||Ariel Miller, MD, PhD||Technion, Israel Institute of Technology, and Carmel Medical Center|