Multiple SclerosisNCT06166043
The Effect of the Nurses Support Program on Fatigue in MS Patient
A study testing NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATION in people with Multiple Sclerosis and Fatigue, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The research will be carried out as a randomized controlled experimental study to examine the effect of a nursing support program supported by a Web-based education program on the management of fatigue symptoms of patients who are under treatment and care in the Multiple Sclerosis clinic of a university… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Fatigue, Sleep Hygiene
- What is being tested?
- NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2023to Mar 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with MS according to McDonald diagnostic criteria at least 6 months ago Being over 18 years old Having voluntarily agreed to participate in the study Having a score below 18 points from the depression tests (Beck Depression Scale), EDSS score <5
Who cannot join
- Presence of a diagnosed psychological illness Having had an attack in the last 3 months Having a score below 24 points in the Mini Mental test evaluation The patient's heart failure Having thyroid hormone imbalance Having uncontrolled and unfollowed anemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficiency of the Nurse Follow-up Program Supported With Web Based Education in Managing Fatigue in Patient With Multiple Sclerosis
The research will be carried out as a randomized controlled experimental study to examine the effect of a nursing support program supported by a Web-based education program on the management of fatigue symptoms of patients who are under treatment and care in the Multiple Sclerosis clinic of a university hospital.Patients will receive 5 weeks of standard care. At the end of 5 weeks, they will enter a training program. After this online training program, which will be 5 weeks and 2 sessions per week, the change in the patients' fatigue, sleep quality and quality of life will be analyzed.
Read the detailed description
Interventions
Groups will be determined in accordance with the randomisation method within the scope of the research for patients who voluntarily agree to participate in the research and meet the inclusion criteria. After the patient is informed about the research in accordance with the group selected, both verbal and written consent will be obtained through the "Voluntary Consent Form".
Control Group: The selected patients will first be included in the control group. Patients will be measured before the study and will receive standard care for 5 weeks without any intervention. At the end of 5 weeks, the measurements of the patients will be repeated. Patients will then be included in the case group. Fatigue Severity Scale, Pittsburg Sleep Quality Scale, EQ5D Quality of Life Scale will be applied to the patients at the beginning and after 5 weeks of receiving standard care.
Case Group: The case group will be included in a 5-week programme including a web-based training programme and nurse follow-up system. This training package, which is determined as 2 days a week for 5 weeks and each session will last 50 minutes, will be carried out through the zoom programme because it is easy to use and adapt. The content of the training is based on fatigue management, taking into account the relevant factors in parallel with the literature. Before the training starts, the patients will be fitted with a smart watch and their step counts and sleep patterns (sleep time, what time they go to bed, deep sleep and light sleep hours) will be monitored for 7 days and this information will be obtained from the patient on a daily basis. They will be informed that they should never take the watch off their wrists and make sure that it works in a healthy way. At the same time, the watch of the researcher and the watch of the participants will be matched to make sure that the watches of the patients are working and measuring simultaneously. Fatigue Severity Scale, Pittsburg Sleep Quality Scale, EQ5D Quality of Life Scale will be applied to the patients. In order to see the behavioural change more clearly after the end of the training, the clock measurements of the patients will be recorded again for 7 days after 1 month and the specified scales will be applied again. At 3 and 6 months, only the scales will be applied again.
Web-based Education Programme After the interviews with the patients, a day and time suitable for the patients will be determined.
WEEK 1: Starting the session, summarising the education plan to be made to the patients, learning the expectations of the patients from the education and ensuring the interaction of mutual group participants. The definition of Multiple Sclerosis, the causes of fatigue in MS and the definition of fatigue will be explained with a Powerpoint presentation (ppt) prepared with literature information. Then patients will be given time to share their experiences. Participants' questions will be answered.
WEEK 2: Training on sleep hygiene and physical exercise will be given. In the first training session of the week, sleep hygiene will be explained. In the second session, exercise will be performed simultaneously with the patients. An exercise plan consisting of stretching-resistance-tension-balance sets will be applied. Patients will be advised to walk for 25 minutes 3 days a week for exercise and the implementation status will be provided and monitored simultaneously with smart watch data.
WEEK 3: Energy conservation training will be explained to patients using interactive methods in the form of Ppt. (Patients will be able to answer the questions asked simultaneously using their mobile phones and patient participation will be ensured by making it visible on the screen by all users) Energy conservation training; It was developed by Packer and colleagues for individuals with chronic diseases that cause fatigue (Blikman et al., 2017). This training includes strategies such as the importance of rest, storing and using energy, appropriate use of body mechanics, organising activities, using assistive technology, setting priorities and standards, and maintaining balance in daily life. It aims to ensure that the individual uses the available energy at the optimum level while fulfilling the activities in daily life.
WEEK 4: Time Management training will be given. It aims to ensure that the individual uses his/her current energy at the optimum level by determining planned and priorities while performing activities in daily life (Audulv et al., 2021).
WEEK 5: Previous trainings will be summarised, patients' feedback will be received. If they have questions, they will be answered. The training will be terminated by ensuring interaction between patients.
Nurse Support Programme
Patients will be called twice a week using a practice list prepared by the researcher and it will be monitored whether the activities on this list are implemented or not. Patients will be reminded of the training time and day by sending SMS 1 day before and 1 hour before the training time, and patients will be prevented from overlooking this information thanks to the simultaneous notification to the smart watch they use. In the same process, patients will be able to reach their nurses via SMS or call at any time with the mobile phone number provided. This support package also includes the follow-up of patients' medication, paperwork on the hospital side, follow-up of patients' appointment processes, follow-up of blood tests during medication use and ensuring that the results are evaluated by appropriate people. Guidance and motivational support will be provided to patients in their processes within the hospital.
- Conditions
- Multiple Sclerosis, Fatigue, Sleep Hygiene, Quality of Life
- Being tested
- NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATION
- Medical subject headings
- Multiple Sclerosis, Fatigue, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATIONBehavioural
An online training consisting of 10 sessions in total for 5 weeks will be given to the patients in order to improve their fatigue management skills. In addition to this training, they will receive a nurse support program.
| Study group | Role | What they receive |
|---|---|---|
| NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATION IN | Experimental | An online training consisting of 10 sessions in total for 5 weeks will be given to the patients in order to improve their fatigue management skills. In addition to this training, they will receive a nurse support program. Receives: Behavioral: NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue levels
Fatigue levels of the patients will be measured before and after the education.Patients' fatigue levels will be measured using the fatigue severity scale. The scale consists of 9 items. It is a scale that the patient can fill in themself.
Measured: The first measurements are made on the patients included in the study. After 5 weeks, the same measurements are made again. The same measurements are made for the patients included in the training 9 weeks and 17 weeks after the start of the training.
Secondary outcomes (2)
sleep quality levels
The sleep quality of the patients will be evaluated with the Pittsburg sleep quality scale, which is a 24-item scale in total. Each item in the scale is scored between 0-3 and the total score varies between 0-21. A total PDQI score greater than five indicates that the sleep quality of the individual is inadequate.
Measured: The first measurements are made on the patients included in the study. After 5 weeks, the same measurements are made again. The same measurements are made for the patients included in the training 9 weeks and 17 weeks after the start of the training.
quality of life levels
The EQ-5D quality of life scale will be used to measure quality of life. The EQ-5D was developed by the EuroQol Group, an international, interdisciplinary group established in 1987 to investigate issues related to the assessment of health. It has been translated into more than 60 languages and is used worldwide. The reliability and validity of the EQ-5D has been established both in general (Brooks \& De Charro, 1996) and in disease-specific groups (Öster et al., 2009; Schrag et al., 2000; Schweikert et al., 2006).
The EQ-5D descriptive system includes five questions covering five dimensions: mobility, self-care, usual activities, pain and anxiety/depression. For each dimension, participants rate their health by reporting whether they experience 1 = "none", 2 = "moderate" or 3 = "extreme problems".Participants receive a score between 0.59 and 1. The higher the score, the better the quality of life.
Measured: The first measurements are made on the patients included in the study. After 5 weeks, the same measurements are made again. The same measurements are made for the patients included in the training 9 weeks and 17 weeks after the start of the training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start30 Jan 2023
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will receive standard care first. The same group of patients will later be included in the intervention.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GİZEM YAĞMUR YALÇIN, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166043
- Sponsor's protocol ID
- 2022/13
- Status last verified
- Dec 2023
- First submitted
- 24 Aug 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yalcin GY, Tulek Z, Kurtuncu M. Effect of a nurse-led online patient support program on fatigue, sleep and quality of life in patients with multiple sclerosis: a quasi-experimental study. BMC Neurol. 2025 May 31;25(1):238. doi: 10.1186/s12883-025-04248-8.
PubMed 40450247
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of the Nurse Follow-up Program Supported With Web Based Education in Managing Fatigue in Patient With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06166043
- Acronym / sponsor ID
- 2022/13
- Conditions
- Multiple Sclerosis, Fatigue, Sleep Hygiene, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 12 Dec 2023 (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.
The research will be carried out as a randomized controlled experimental study to examine the effect of a nursing support program supported by a Web-based education program on the management of fatigue symptoms of patients who are under treatment and care in the Multiple Sclerosis clinic of a university hospital.Patients will receive 5 weeks of standard care. At the end of 5 weeks, they will enter a training program. After this online training program, which will be 5 weeks and 2 sessions per week, the change in the patients' fatigue, sleep quality and quality of life will be analyzed.
Detailed description
Interventions
Groups will be determined in accordance with the randomisation method within the scope of the research for patients who voluntarily agree to participate in the research and meet the inclusion criteria. After the patient is informed about the research in accordance with the group selected, both verbal and written consent will be obtained through the "Voluntary Consent Form".
Control Group: The selected patients will first be included in the control group. Patients will be measured before the study and will receive standard care for 5 weeks without any intervention. At the end of 5 weeks, the measurements of the patients will be repeated. Patients will then be included in the case group. Fatigue Severity Scale, Pittsburg Sleep Quality Scale, EQ5D Quality of Life Scale will be applied to the patients at the beginning and after 5 weeks of receiving standard care.
Case Group: The case group will be included in a 5-week programme including a web-based training programme and nurse follow-up system. This training package, which is determined as 2 days a week for 5 weeks and each session will last 50 minutes, will be carried out through the zoom programme because it is easy to use and adapt. The content of the training is based on fatigue management, taking into account the relevant factors in parallel with the literature. Before the training starts, the patients will be fitted with a smart watch and their step counts and sleep patterns (sleep time, what time they go to bed, deep sleep and light sleep hours) will be monitored for 7 days and this information will be obtained from the patient on a daily basis. They will be informed that they should never take the watch off their wrists and make sure that it works in a healthy way. At the same time, the watch of the researcher and the watch of the participants will be matched to make sure that the watches of the patients are working and measuring simultaneously. Fatigue Severity Scale, Pittsburg Sleep Quality Scale, EQ5D Quality of Life Scale will be applied to the patients. In order to see the behavioural change more clearly after the end of the training, the clock measurements of the patients will be recorded again for 7 days after 1 month and the specified scales will be applied again. At 3 and 6 months, only the scales will be applied again.
Web-based Education Programme After the interviews with the patients, a day and time suitable for the patients will be determined.
WEEK 1: Starting the session, summarising the education plan to be made to the patients, learning the expectations of the patients from the education and ensuring the interaction of mutual group participants. The definition of Multiple Sclerosis, the causes of fatigue in MS and the definition of fatigue will be explained with a Powerpoint presentation (ppt) prepared with literature information. Then patients will be given time to share their experiences. Participants' questions will be answered.
WEEK 2: Training on sleep hygiene and physical exercise will be given. In the first training session of the week, sleep hygiene will be explained. In the second session, exercise will be performed simultaneously with the patients. An exercise plan consisting of stretching-resistance-tension-balance sets will be applied. Patients will be advised to walk for 25 minutes 3 days a week for exercise and the implementation status will be provided and monitored simultaneously with smart watch data.
WEEK 3: Energy conservation training will be explained to patients using interactive methods in the form of Ppt. (Patients will be able to answer the questions asked simultaneously using their mobile phones and patient participation will be ensured by making it visible on the screen by all users) Energy conservation training; It was developed by Packer and colleagues for individuals with chronic diseases that cause fatigue (Blikman et al., 2017). This training includes strategies such as the importance of rest, storing and using energy, appropriate use of body mechanics, organising activities, using assistive technology, setting priorities and standards, and maintaining balance in daily life. It aims to ensure that the individual uses the available energy at the optimum level while fulfilling the activities in daily life.
WEEK 4: Time Management training will be given. It aims to ensure that the individual uses his/her current energy at the optimum level by determining planned and priorities while performing activities in daily life (Audulv et al., 2021).
WEEK 5: Previous trainings will be summarised, patients' feedback will be received. If they have questions, they will be answered. The training will be terminated by ensuring interaction between patients.
Nurse Support Programme
Patients will be called twice a week using a practice list prepared by the researcher and it will be monitored whether the activities on this list are implemented or not. Patients will be reminded of the training time and day by sending SMS 1 day before and 1 hour before the training time, and patients will be prevented from overlooking this information thanks to the simultaneous notification to the smart watch they use. In the same process, patients will be able to reach their nurses via SMS or call at any time with the mobile phone number provided. This support package also includes the follow-up of patients' medication, paperwork on the hospital side, follow-up of patients' appointment processes, follow-up of blood tests during medication use and ensuring that the results are evaluated by appropriate people. Guidance and motivational support will be provided to patients in their processes within the hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will receive standard care first. The same group of patients will later be included in the intervention.
| Arm | Type | Receives |
|---|---|---|
| NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATION IN | Experimental | Behavioral: NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATIONAn online training consisting of 10 sessions in total for 5 weeks will be given to the patients in order to improve their fatigue management skills. In addition to this training, they will receive a nurse support program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being diagnosed with MS according to McDonald diagnostic criteria at least 6 months ago Being over 18 years old Having voluntarily agreed to participate in the study Having a score below 18 points from the depression tests (Beck Depression Scale), EDSS score <5
Key exclusion criteria (1 listed)
- Presence of a diagnosed psychological illness Having had an attack in the last 3 months Having a score below 24 points in the Mini Mental test evaluation The patient's heart failure Having thyroid hormone imbalance Having uncontrolled and unfollowed anemia
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 |
|---|---|---|
| NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATIONAn online training consisting of 10 sessions in total for 5 weeks will be given to the patients in order to improve their fatigue management skills. In addition to this training, they will receive a nurse support program. | Behavioural | NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATION IN |
Primary outcome
Fatigue levels
Time frame: The first measurements are made on the patients included in the study. After 5 weeks, the same measurements are made again. The same measurements are made for the patients included in the training 9 weeks and 17 weeks after the start of the training.
Fatigue levels of the patients will be measured before and after the education.Patients' fatigue levels will be measured using the fatigue severity scale. The scale consists of 9 items. It is a scale that the patient can fill in themself.
2 secondary outcomes
sleep quality levels
Time frame: The first measurements are made on the patients included in the study. After 5 weeks, the same measurements are made again. The same measurements are made for the patients included in the training 9 weeks and 17 weeks after the start of the training.
quality of life levels
Time frame: The first measurements are made on the patients included in the study. After 5 weeks, the same measurements are made again. The same measurements are made for the patients included in the training 9 weeks and 17 weeks after the start of the training.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Derived from this study: PubMed 40450247Yalcin GY, Tulek Z, Kurtuncu M. Effect of a nurse-led online patient support program on fatigue, sleep and quality of life in patients with multiple sclerosis: a quasi-experimental study. BMC Neurol. 2025 May 31;25(1):238. doi: 10.1186/s12883-025-04248-8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATION in people with Multiple Sclerosis and Fatigue, run by Istanbul University - Cerrahpasa 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 1 inclusion and 1 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 12 Dec 2023. 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?
Fatigue levels (time frame: The first measurements are made on the patients included in the study. After 5 weeks, the same measurements are made again. The same measurements are made for the patients included in the training 9 weeks and 17 weeks after the start of the training.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06166043, which also lists 1 linked publication.
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 12 Dec 2023.