跳至主要内容
临床试验/NCT05209113
NCT05209113Unknown不适用

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

Hacettepe University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Changes in the self-management scale (Multiple Sclerosis Self Management Revised) scores of patients after the implementation of the self-management module

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

The patients included in the study do not know which group they will be included in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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.

干预措施: Education (Other)

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.

结局指标

主要结局

Changes in the self-management scale (Multiple Sclerosis Self Management Revised) scores of patients after the implementation of the self-management module

时间窗: 20 months

Changes in patients' self-management in the short (4 months) and long (8 months) term will be evaluated using the MSSM-R scale.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cansu Goncuoglu

Assistant

Hacettepe University

研究点 (1)

Loading locations...

相似试验