Development and Evaluation of the Self-management Module in Patients With Multiple Sclerosis

Compared with other chronic disease states, MS patients feel more uncertainty and less control over illness and non-illness aspects of life, and as a result, they have poor self-management abilities. It was thought that providing evidence-based information and using balanced information in terms of risk/benefit in patient education would affect the patient's self management. It is thought that a developed comprehensive self-management module by clinical pharmacist will contribute to the literature and clinical practice, and will positively affect the treatment process of patients.

This study is aimed to improve the self-management of MS patients by informing them about the disease, treatment options, and appropriate drug use by the clinical pharmacist, and to analyze the effect of the self-management module in the short and long term by examining the change in patients' self-management, participation in the treatment process and care satisfaction and compliance.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Education

Detailed Description

Multiple Sclerosis (MS) is a chronic, progressive central nervous system disease that cannot be cured in the light of current information. Disability, weakness, tremors, balance and movement problems, fatigue and depression are observed in the vast majority of MS patients. Compared with other chronic disease states, MS patients feel more uncertainty and less control over illness and non-illness aspects of life, and as a result, they have poor self-management abilities. Self-management can be defined as an individual's ability to manage symptoms, treatment, physical and psychological consequences of illness, and making lifestyle changes specific to living with a chronic condition. In studies, it was thought that providing evidence-based information and using balanced information in terms of risk/benefit in patient education would affect the patient's participation in the shared decision-making process. Self-management programs for MS patients are insufficient and this is a factor in the failure of self-management to be fully adopted. It was revealed that self-efficacy, perception of treatment control, and realistic MS process knowledge were associated with self-management in MS patients. It is thought that a developed comprehensive self-management module will contribute to the literature and clinical practice, and will positively affect the treatment process of patients. Clinical pharmacy is defined by the American College of Clinical Pharmacy as a health science offered by the pharmacist in order to organize the patient's drug therapy in the most appropriate way and to protect health, ensure healing and prevent disease. Accordingly, the clinical pharmacist is responsible for identifying and preventing the patient's possible problems with drug therapy (such as drug dose/dosing frequency/administration route suitability, drug interactions, side effects, compliance, education and information needs, therapeutic drug monitoring requirement), and other healthcare professionals. It takes part in cooperation with the multidisciplinary team, provides necessary information about drugs and ensures the continuation of rational drug treatment. Studies have reported that as a result of the integration of the clinical pharmacist into the MS outpatient clinic, patients' access to drugs is facilitated, care coordination and patient outcomes are improved. In addition, it has been shown that the presence of a clinical pharmacist in a multidisciplinary team contributes to increasing compliance, making drug follow-ups of patients, and improving communication with physicians. As a result of all these, the self-confidence of the patient, who played a key role in the joint decision-making model, increased and it was observed that the patients were more willing to be involved in the joint decision-making process.

The aim of this study is to improve the self-management of MS patients by informing them about the disease, treatment options, and appropriate drug use by the clinical pharmacist, and to analyze the effect of the self-management module in the short term (4 months) and long term (8 months) by examining the change in patients' self-management, participation in the treatment process and care satisfaction and compliance.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sihhiye
    • Ankara, Sihhiye, Turkey, 06100
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• over 18 years old,
• Diagnosed with MS and using medication for at least 45 days,
• Approved by the physician to participate in the study,
• Giving written consent,
• Patients who have been in a stable disease period (attack free period) for at least 30 days

Exclusion Criteria:

• Has a disability that prevents communication,
• Involved in another clinical and/or drug trial,
• Patients who are pregnant / planning pregnancy during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; The self-management module, which will be applied only to the study group, includes the clinical pharmacist informing the patient verbally and in writing about MS disease, the importance of drug compliance, and monitoring of disease symptoms. The first interview will end after the Patient Health Engagement-PHE-s, Multiple Sclerosis Self-Management Revised-MSSM-R, Patient Assessment of Chronic Illness Care-PACIC scales and self-management module are applied to the study group by the clinical pharmacist. When the patients come to the outpatient clinic examination 4 and 8 months after the first interview, second and third face-to-face interview will be held with the clinical pharmacist and all scales will be applied again. During the second and third interview, no written and/or verbal information will be given to the patient again.	Other: Education; A self-management module was applied to the study group. This module includes informing the patient verbally and in writing about MS disease, the importance of drug compliance, and monitoring of disease symptoms.
No Intervention: Control Group; Patient Health Engagement (PHE-s), Multiple Sclerosis Self-Management Revised (MSSM-R), Patient Assessment of Chronic Illness Care (PACIC) scales will be administered to the control group patients whose medications and demographic information were obtained in the first face-to-face interview. The same scales will be repeated at the 4th month and 8th month, the self-management module will not be applied to the control group, and within this scope, the patients will not be informed by the clinical pharmacist, and the patient's routine outpatient services will continue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the self-management scale (Multiple Sclerosis Self Management Revised) scores of patients after the implementation of the self-management module	Changes in patients' self-management in the short (4 months) and long (8 months) term will be evaluated using the MSSM-R scale.	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the patient engagement (Patient Health Engagement Scale) scores of patients after the implementation of the self-management module	Changes in patients' health engagement score in the short (4 months) and long (8 months) term will be evaluated using the PHE scale.	20 months
Changes in the perception of care (Patient Assessment of Chronic Illness Care-PACIC) scores of patients after the implementation of the self-management module	Changes in patients' perception of care in the short (4 months) and long (8 months) term will be evaluated using the Patient Assessment of Chronic Illness Care-PACIC scale.	20 months

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Chair: Asli Tuncer, Hacettepe University Department of Neurology

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): December 15, 2021
• Study Completion (Anticipated): September 15, 2022

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: self management; treatment adherence; clinical pharmacist; disease modifying treatments
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: KA-20003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No