Multiple SclerosisNCT05393765
The Effect of an Interactive Web-based Program in the Management of Multiple Sclerosis
A study testing Yönetebilirim in people with Multiple Sclerosis, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effect of an interactive web-based program that supports nurse-led self-regulation in the management of Multiple Sclerosis (MS) on the self-management, fatigue and anxiety levels of patients with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Yönetebilirim
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jun 2022to 1 Jun 2023
- 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
- To be diagnosed with Multiple Sclerosis,
- Expanded Disability Status Scale (EDSS) score below 5,
- Be in the 7-12 age range18-65,
- Having the ability to read and write,
- To be able to communicate in Turkish
- Being able to access and use the Internet (computer, tablet, mobile phone)
Who cannot join
- To have received steroid treatment for an attack in the last month
- Having a psychiatric diagnosis (schizophrenia, bipolar affective disorder etc.)
- Having advanced cognitive problems
- Being visually and hearing impaired.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of the Effect of an Interactive Web-based Program That Supports Nurse-led Self-regulation in the Management of Multiple Sclerosis
This study aimed to investigate the effect of an interactive web-based program that supports nurse-led self-regulation in the management of Multiple Sclerosis (MS) on the self-management, fatigue and anxiety levels of patients with Multiple Sclerosis.
Read the detailed description
Detailed Description: Individuals with Multiple Sclerosis are diagnosed at a young age and face a long-term, heterogeneous disease process with effects on multiple functional areas. As in other chronic diseases, individuals with MS need to develop self-management skills in order to be integrated into society, to have an increased quality of life, to reduce the burden of symptoms, to prevent disability, and to maintain psychosocial well-being. In order to improve self-management skills, it is important for the healthcare team to have a supervisory and educational role and to carry out the clinical and social follow-up of these individuals closely. Studies have shown that those with MS do not generally use health services except for the attack periods or they have problems in reaching the health care team due to reasons such as fatigue and disability. It is reported that individuals with MS mostly seek information on the Internet, on social media or from peers, and they do not consult the healthcare team about this inaccurate or insufficient information. All these factors clearly indicate that digital health (e-health) services should become widespread alongside traditional health services in order to improve the self-management skills of individuals with MS.
It is seen in the literature that various web-based programs with different interfaces and features have been developed by different healthcare team members for individuals with MS; however, many of these programs have not been evaluated in randomized controlled studies and are not nurse-led. MS is considered as a very long journey for individuals and their families, and nurses accompany individuals with MS and their families as a leading force to support self-management throughout this journey. No interactive web-based programs have been developed to support the self-management skills of individuals with MS in Turkey. Considering that this is an important gap, an interactive web-based program named "Yönetebilirim", which supports self-regulation under the leadership of nurses, was developed. This study aims to evaluate the effect of "Yönetebilirim" on self-management, fatigue and anxiety levels of individuals with MS with a randomized controlled design.
Yönetebilirim "Yönetebilirim" is an interactive web-based program developed to improve the self-management skills of individuals with MS by supporting self-regulation under the leadership of nurses. The program was shaped in accordance with action research in a collaborative design and was implemented between February 2021 and May 2022 with the approval of the non-interventional clinical research ethics committee of a university (2021/61). Under the coordination of the action researcher (program coordinator), the components of the web-based program were shaped by individuals with MS, nurses caring for individuals with MS, and software specialists. The self-regulation strategies formed the theoretical basis of the web-based program. The domain name of the program has been taken and its address has been determined as "yonetebilirim.com".
The program consists of modules and consultancy services. Modules There are a total of 10 modules in the program and the modules are presented under two headings as "Informative" and "Interactive". The topics of the modules are as follows: Recognizing MS and Attack management, Coping with fatigue, Sexual health, Bladder and Urinary problems, Self-monitoring, Healthy lifestyle behaviors, Importance of physiotherapy, MS Stories and Laughter therapy. The speakers in the modules are a specialist neurologist, academician nurses, specialist nurses, a specialist physiotherapist, and a laughter therapist who voluntarily agreed to support the program. The modules consist of discussion sessions based on the program coordinator's questions and the speakers' answers. The content of the videos was created by the speakers according to their fields of expertise. The informative modules include video recordings and written documents aiming at sharing information. The interactive modules consist of interactive live webinars created to increase motivation.
Consultancy Services After the participants are accepted to the program, they will be able to access the program with their own username and password. Participants will be able to receive counseling from the nurse with a written message using the "Consult" link on the main screen of the program, and the nurse will be able to answer questions through the system. If they wish, participants will be able to make an appointment to meet online with the video conference method by clicking on the "Request a Meeting" link.
- Conditions
- Multiple Sclerosis
- Being tested
- Yönetebilirim
- Keywords
- Multiple Sclerosis, Self-Management, Nursing, Self-Regulation
- Medical subject headings
- Multiple Sclerosis, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YönetebilirimBehavioural
"Yönetebilirim" is an interactive web-based program developed to improve the self-management skills of individuals with MS by supporting self-regulation under the leadership of nurses.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Experimental: Intervention group "Yönetebilirim" Before the initiation of the program, patients who visit the outpatient clinic will be evaluated according to the inclusion-exclusion criteria, their consent will be obtained, and pre-tests will be administered. Then, randomization will be performed and participants will be assigned to the experimental and control groups. Participants in the experimental group will be registered on the web-based program. The individuals in the experimental group will use "Yönetebilirim" for 8 weeks as of the time the program is put into use. "Yönetebilirim" consists of modules and consultancy services. Participants will be able to watch informative videos as much as they want for 8 weeks and receive consultancy service if they wish. Receives: Behavioral: Yönetebilirim |
| Control | No intervention | The control group will receive standard care without any intervention. The group will not receive any other intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-management
The Multiple Sclerosis Self-Management Scale (MSSM) will be used to assess self-management knowledge and behavior of individuals with MS comprehensively and psychometrically. The MSSM consists of 24 Likert-type items with re-sponses as follows: disagree completely (1 point), somewhat disagree (2 points), neither agree nor dis-agree (3 points), somewhat agree (4 points), and agreecompletely (5 points). The MSSM includes 5 subscales: healthcare providerrelationship/communication, treatment adherence/barriers, social/family support, MS knowledge and information, and health maintenance behavior. Total score ranges between 0 and 100, and a higherscore indicates a higher degree of self-management.
Measured: Baseline and 8 weeks after patient inclusion
Secondary outcomes (4)
Fatigue Severity Scale
The scale, which evaluates fatigue in the last month, consists of 9 items and is a 7-point Likert type. The scale has only one sub-dimension and each question is evaluated between 1-7 points. The lowest score that can be obtained from the salep item is 1 and the highest score is 7. The total score in the scale is calculated by taking the average of 9 items. A score of four or more generally indicates severe fatigue. As the score obtained from the scale increases, the degree of fatigue also increases.
Measured: Baseline and 8 weeks after patient inclusion
State-Trait Anxiety Inventory (STAI)
State-Trait Anxiety Inventory (STAI) is self-report questionnaire consists of two subscales each containing 40 items, 20 item state, 20 item trait. All items are rated on a 4-point scale. Higher scores indicate greater anxiety. The scale is evaluated over the total score, and as the score obtained from the scale increases, the level of anxiety also increases. In the score calculation, the score obtained for the direct statements is subtracted from the score obtained for the reverse statements. This value is added to the constant value of 35 for the Trait Anxiety Scale. Bigger score indicates high anxiety level; small score indicates low anxiety level.
Measured: Baseline and 8 weeks after patient inclusion
System Usability Scale
System Usability Scale consists of a 10 item questionnaire with five response options for respondents; from Strongly agree (5 point) to Strongly disagree (1 point). For each of the odd numbered questions, subtract 1 from the score. For each of the even numbered questions, subtract their value from 5.Take these new values which you have found, and add up the total score. Then multiply this by 2.5. The scores of scale are 0-100. The scale score above a 68 would be considered above average and anything below 68 is below average.
Measured: 8 weeks after patient inclusion
Program Usage Level Tracking Form
In the research, the level of use of "Yönetebilirim" and the participation status of the participants in the experimental group will be evaluated with a 7-question program usage level follow-up form created by the researcher. The form will be filled by the researcher according to the data recorded by the program.
Measured: 8 weeks after patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start13 Jun 2022
- Primary completion1 Sep 2022
- Study completion1 Jun 2023
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.
- 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
- A randomized controlled trial with a two-group pre-test and post-test design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayyuce Tuba Kocak, Selcuk University
- Investigators
- Selda Arslan, Phd, Study director, Necmettin Erbakan University Faculty of NursingAyyüce Tuba Koçak, MSC, Principal investigator, Selcuk University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393765
- Sponsor's protocol ID
- 2022/33
- Status last verified
- Sep 2023
- First submitted
- 20 May 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effect of an Interactive Web-based Program That Supports Nurse-led Self-regulation in the Management of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05393765
- Acronym / sponsor ID
- 2022/33
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Self-Management, Nursing, Self-Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 26 May 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.
This study aimed to investigate the effect of an interactive web-based program that supports nurse-led self-regulation in the management of Multiple Sclerosis (MS) on the self-management, fatigue and anxiety levels of patients with Multiple Sclerosis.
Detailed description
Detailed Description: Individuals with Multiple Sclerosis are diagnosed at a young age and face a long-term, heterogeneous disease process with effects on multiple functional areas. As in other chronic diseases, individuals with MS need to develop self-management skills in order to be integrated into society, to have an increased quality of life, to reduce the burden of symptoms, to prevent disability, and to maintain psychosocial well-being. In order to improve self-management skills, it is important for the healthcare team to have a supervisory and educational role and to carry out the clinical and social follow-up of these individuals closely. Studies have shown that those with MS do not generally use health services except for the attack periods or they have problems in reaching the health care team due to reasons such as fatigue and disability. It is reported that individuals with MS mostly seek information on the Internet, on social media or from peers, and they do not consult the healthcare team about this inaccurate or insufficient information. All these factors clearly indicate that digital health (e-health) services should become widespread alongside traditional health services in order to improve the self-management skills of individuals with MS.
It is seen in the literature that various web-based programs with different interfaces and features have been developed by different healthcare team members for individuals with MS; however, many of these programs have not been evaluated in randomized controlled studies and are not nurse-led. MS is considered as a very long journey for individuals and their families, and nurses accompany individuals with MS and their families as a leading force to support self-management throughout this journey. No interactive web-based programs have been developed to support the self-management skills of individuals with MS in Turkey. Considering that this is an important gap, an interactive web-based program named "Yönetebilirim", which supports self-regulation under the leadership of nurses, was developed. This study aims to evaluate the effect of "Yönetebilirim" on self-management, fatigue and anxiety levels of individuals with MS with a randomized controlled design.
Yönetebilirim "Yönetebilirim" is an interactive web-based program developed to improve the self-management skills of individuals with MS by supporting self-regulation under the leadership of nurses. The program was shaped in accordance with action research in a collaborative design and was implemented between February 2021 and May 2022 with the approval of the non-interventional clinical research ethics committee of a university (2021/61). Under the coordination of the action researcher (program coordinator), the components of the web-based program were shaped by individuals with MS, nurses caring for individuals with MS, and software specialists. The self-regulation strategies formed the theoretical basis of the web-based program. The domain name of the program has been taken and its address has been determined as "yonetebilirim.com".
The program consists of modules and consultancy services. Modules There are a total of 10 modules in the program and the modules are presented under two headings as "Informative" and "Interactive". The topics of the modules are as follows: Recognizing MS and Attack management, Coping with fatigue, Sexual health, Bladder and Urinary problems, Self-monitoring, Healthy lifestyle behaviors, Importance of physiotherapy, MS Stories and Laughter therapy. The speakers in the modules are a specialist neurologist, academician nurses, specialist nurses, a specialist physiotherapist, and a laughter therapist who voluntarily agreed to support the program. The modules consist of discussion sessions based on the program coordinator's questions and the speakers' answers. The content of the videos was created by the speakers according to their fields of expertise. The informative modules include video recordings and written documents aiming at sharing information. The interactive modules consist of interactive live webinars created to increase motivation.
Consultancy Services After the participants are accepted to the program, they will be able to access the program with their own username and password. Participants will be able to receive counseling from the nurse with a written message using the "Consult" link on the main screen of the program, and the nurse will be able to answer questions through the system. If they wish, participants will be able to make an appointment to meet online with the video conference method by clicking on the "Request a Meeting" link.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial with a two-group pre-test and post-test design
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: YönetebilirimExperimental: Intervention group "Yönetebilirim" Before the initiation of the program, patients who visit the outpatient clinic will be evaluated according to the inclusion-exclusion criteria, their consent will be obtained, and pre-tests will be administered. Then, randomization will be performed and participants will be assigned to the experimental and control groups. Participants in the experimental group will be registered on the web-based program. The individuals in the experimental group will use "Yönetebilirim" for 8 weeks as of the time the program is put into use. "Yönetebilirim" consists of modules and consultancy services. Participants will be able to watch informative videos as much as they want for 8 weeks and receive consultancy service if they wish. |
| Control | No intervention | –The control group will receive standard care without any intervention. The group will not receive any other intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To be diagnosed with Multiple Sclerosis,
- Expanded Disability Status Scale (EDSS) score below 5,
- Be in the 7-12 age range18-65,
- Having the ability to read and write,
- To be able to communicate in Turkish
Key exclusion criteria (4 listed)
- To have received steroid treatment for an attack in the last month
- Having a psychiatric diagnosis (schizophrenia, bipolar affective disorder etc.)
- Having advanced cognitive problems
- Being visually and hearing impaired.
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 |
|---|---|---|
| Yönetebilirim"Yönetebilirim" is an interactive web-based program developed to improve the self-management skills of individuals with MS by supporting self-regulation under the leadership of nurses. | Behavioural | experimental |
Primary outcome
Change in self-management
Time frame: Baseline and 8 weeks after patient inclusion
The Multiple Sclerosis Self-Management Scale (MSSM) will be used to assess self-management knowledge and behavior of individuals with MS comprehensively and psychometrically. The MSSM consists of 24 Likert-type items with re-sponses as follows: disagree completely (1 point), somewhat disagree (2 points), neither agree nor dis-agree (3 points), somewhat agree (4 points), and agreecompletely (5 points). The MSSM includes 5 subscales: healthcare providerrelationship/communication, treatment adherence/barriers, social/family support, MS knowledge and information, and health maintenance behavior. Total score ranges between 0 and 100, and a higherscore indicates a higher degree of self-management.
4 secondary outcomes
Fatigue Severity Scale
Time frame: Baseline and 8 weeks after patient inclusion
State-Trait Anxiety Inventory (STAI)
Time frame: Baseline and 8 weeks after patient inclusion
System Usability Scale
Time frame: 8 weeks after patient inclusion
Program Usage Level Tracking Form
Time frame: 8 weeks after patient inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Yes
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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.
Selda Arslan, Phd study director
Necmettin Erbakan University Faculty of Nursing
Ayyüce Tuba Koçak, MSC principal investigator
Selcuk University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yönetebilirim in people with Multiple Sclerosis, run by Selcuk 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 13 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in self-management (time frame: Baseline and 8 weeks after patient inclusion). 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 13 Sep 2023.