The Effect of an Interactive Web-based Program in the Management of Multiple Sclerosis

NCT05393765 | Completed DMC

• 1 other identifier: 2022/33
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Self-Management; Nursing; Self-Regulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 8 weeks after patient inclusion

Secondary Outcomes (4)

• Fatigue Severity Scale

  Baseline and 8 weeks after patient inclusion

• State-Trait Anxiety Inventory (STAI)

  Baseline and 8 weeks after patient inclusion

• System Usability Scale

  8 weeks after patient inclusion

• Program Usage Level Tracking Form

  8 weeks after patient inclusion

Study Arms (2)

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.

Behavioral: Yönetebilirim

Control

NO INTERVENTION

The control group will receive standard care without any intervention. The group will not receive any other intervention.

Interventions

Yönetebilirim BEHAVIORAL

"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.

experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Selçuklu, Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Self-Control

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Social Behavior; Behavior

Study Officials

• Selda Arslan, Phd

  Necmettin Erbakan University Faculty of Nursing

  STUDY DIRECTOR

• Ayyüce Tuba Koçak, MSC

  Selcuk University Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: A randomized controlled trial with a two-group pre-test and post-test design

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 26, 2022
• Study Start: June 13, 2022
• Primary Completion: September 1, 2022
• Study Completion: June 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 mounts later

Locations

TU (1)