Clinical trial NCT05393765: The Effect of an Interactive Web-based Program in the Management of Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Self-Management
Nursing
Self-Regulation
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial with a two-group pre-test and post-test design
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in self-management
timeFrame: Baseline and 8 weeks after patient inclusion
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: Baseline and 8 weeks after patient inclusion
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline and 8 weeks after patient inclusion
measure: System Usability Scale
timeFrame: 8 weeks after patient inclusion
measure: Program Usage Level Tracking Form
timeFrame: 8 weeks after patient inclusion
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: Selcuk University
state: Konya
Study officials:
affiliation: Necmettin Erbakan University Faculty of Nursing
name: Selda Arslan, Phd
role: STUDY_DIRECTOR
affiliation: Selcuk University Faculty of Nursing
name: Ayyüce Tuba Koçak, MSC
role: PRINCIPAL_INVESTIGATOR
References: