Multiple SclerosisNCT05209113
Development and Evaluation of the Self-management Module in Patients With Multiple Sclerosis
A study testing Education in people with Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2020to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has a disability that prevents communication,
- Involved in another clinical and/or drug trial,
- Patients who are pregnant / planning pregnancy during the study period
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Education
- Keywords
- self management, disease modifying treatments, clinical pharmacist, treatment adherence
- Medical subject headings
- Multiple Sclerosis, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
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 | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Changes in patients' health engagement score in the short (4 months) and long (8 months) term will be evaluated using the PHE scale.
Measured: 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.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start15 Sep 2020
- Primary completion15 Dec 2021
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Goncuoglu, Hacettepe University
- Investigators
- Asli Tuncer, Study chair, Hacettepe University Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209113
- Sponsor's protocol ID
- KA-20003
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of the Self-management Module in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05209113
- Acronym / sponsor ID
- KA-20003
- Conditions
- Multiple Sclerosis
- Keywords
- self management, disease modifying treatments, clinical pharmacist, treatment adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: EducationThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Has a disability that prevents communication,
- Involved in another clinical and/or drug trial,
- Patients who are pregnant / planning pregnancy during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationA 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. | Other | Study Group |
Primary outcome
Changes in the self-management scale (Multiple Sclerosis Self Management Revised) scores of patients after the implementation of the self-management module
Time frame: 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.
2 secondary outcomes
Changes in the patient engagement (Patient Health Engagement Scale) scores of patients after the implementation of the self-management module
Time frame: 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
Time frame: 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asli Tuncer study chair
Hacettepe University Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the self-management scale (Multiple Sclerosis Self Management Revised) scores of patients after the implementation of the self-management module (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.