Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05393765 |
| Other study ID # |
2022/33 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 13, 2022 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Selcuk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
