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

NCT05209113 | Unknown

• 1 other identifier: KA-20003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

self management; disease modifying treatments; clinical pharmacist; treatment adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in the patient engagement (Patient Health Engagement Scale) scores of patients after the implementation of the self-management module

  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

  20 months

Study Arms (2)

Study Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Education OTHER

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.

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Sihhiye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Treatment Adherence and Compliance

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Asli Tuncer

  Hacettepe University Department of Neurology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients included in the study do not know which group they will be included in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant

Model Details: This study was designed as a randomized controlled trial. Patient groups were determined by a biostatistician using the block randomization method. The block width is taken as 4 and seed number fixed at 123.

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 26, 2022
• Study Start: September 15, 2020
• Primary Completion: December 15, 2021
• Study Completion: September 15, 2022
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)