NCT06166043

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

August 24, 2023

Last Update Submit

December 10, 2023

Conditions

Multiple SclerosisFatigueSleep HygieneQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 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 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.

Study Arms (1)

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.

Behavioral: NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATION

Interventions

NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATIONBEHAVIORAL

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.

NURSE FOLLOW-UP PROGRAM SUPPORTED WITH WEB-BASED EDUCATION IN

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gizem Yağmur Yalçın

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 40450247DERIVED

MeSH Terms

Conditions

Multiple SclerosisFatigueSleep Hygiene

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Patients will receive standard care first. The same group of patients will later be included in the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2023

First Posted

December 12, 2023

Study Start

January 30, 2023

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)