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

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ClinicalTrials.gov Identifier: NCT02488343
Recruitment Status : Recruiting
First Posted : July 2, 2015
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Ariel Miller, Carmel Medical Center

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Behavioral Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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.


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • pregnant women

Information from the National Library of Medicine

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


Contacts
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Contact: Ariel Miller, MD, PhD 972-4-8250851 milleras@netvision.net.il

Locations
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Israel
MS Clinic, Carmel Medical Center Recruiting
Haifa, Israel
Contact: Ariel Miller, MD PhD    972-4-8250851    Ariel_Miller@clalit.org.il   
Principal Investigator: Ariel Miller, MD PhD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
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Principal Investigator: Ariel Miller, MD, PhD Technion, Israel Institute of Technology, and Carmel Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ariel Miller, Director of Multiple Sclerosis & Brain Research Center, Carmel Medical Center, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT02488343    
Other Study ID Numbers: CMC-14-0061-CTIL
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021
Keywords provided by Ariel Miller, Carmel Medical Center:
Multiple Sclerosis
Adherence
Therapies
Psychological Intervention
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases