Making it Personal: Identifying Personalised Triggers of Fatigue in Multiple Sclerosis

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12620000908932
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-14
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Individuals who:
(1) have a diagnosis of multiple sclerosis, as confirmed by GP
(2) are aged 18 years or older
(3) live in Greater Brisbane
(4) have access to the internet to complete an online questionnaire
(5) are willing to complete brief questionnaires via an electronic diary each day for 6 weeks
(6) have a score on the Modified Fatigue Impact Scale above the age-, gender- and education-specific norm cut-offs
(7) have been on a stable dose of medication for at least 1 month, as confirmed by GP

Exclusion Criteria

Individuals who have:
(1) acquired brain injury
(2) active psychiatric disorder (e.g. schizophrenia),
(3) cognitive impairment
(4) sleep disorder or
(5) other relevant progressive neurological disorders

The individual's GP will determine whether they meet any of the exclusion criteria.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The severity of fatigue measured on a visual analogue scale ranging from 0 to 100. The measure is designed specifically for this study. The data is analysed at the individual (N-of-1) level. [ Three times per day (morning, afternoon and evening) for 6-18 weeks (duration of data collection period based on the preference of the participant).<br>]

Secondary Outcome Measures

Name	Time	Method
The severity of a personally-relevant symptom (e.g. body pain) selected by the participant at the start of the study measured on a visual analogue scale ranging from 0 to 100. The measure is designed specifically for this study. The data is analysed at the individual (N-of-1) level. If more than one symptom is selected by the participant, it will be analysed as another secondary outcome (i.e. not a composite measure).[ Three times per day (morning, afternoon and evening) for 6-18 weeks (duration of data collection period based on the preference of the participant).<br>];Acceptability of the study procedures[ Semi-structured interviews will be conducted at the end of the study to explore participant views about the study procedures];Feasibility of study procedures[ Feasibility will be assessed by calculating the recruitment/retention rate and completion rate of daily questionnaires during the study for each participant after the data collection period is completed.<br><br>]