Effectiveness of Fatigue and Activity Management in Work (FAME-W) for Individuals With Inflammatory Arthritis

NCT05138445 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-12-01

No results posted yet for this study

Summary

Many individuals with Inflammatory Arthritis (IA) experience symptoms of pain and fatigue which interfere with work. Over 50% of people with IA report workplace difficulties resulting in sick leave, absenteeism and reduced productivity. Loss of ability to continue paid employment results in physical, emotional and financial hardship for individuals with IA and has societal and economic implications. Previous research has identified pain and fatigue as dominant symptoms that interfere with work capacity and therefore interventions are required to reduce the impact of these symptoms on work activities. The purpose of this study therefore is to test the effectiveness of a 4-week Fatigue and Activity Management Education for Work intervention. The study will use a mixed methods design. A randomized control trial will test the effectiveness of the intervention and a qualitative process evaluation with explore acceptability and participants' experiences of the intervention. Individuals with IA, of working age, will be recruited in Rheumatology outpatient departments of three hospitals. Study participants will be randomly assigned to a four-week online self-management intervention or a self-guided symptom management workbook. Study measures consist of self-report questionnaires related to work and symptom management. All participants will also be invited to an interview to discuss their experience of participating in the study.

Conditions

  • Inflammatory Arthritis

Interventions

BEHAVIORAL

FAME-W self-management intervention

FAME-W is an occupational therapy led, four-week group based self-management intervention. It focuses on providing people with IA skills and confidence to manage demands of their employment and daily life through education on IA, self-management techniques, managing symptoms of fatigue, pain and stress and managing physical and mental health.

BEHAVIORAL

FAME-W Handbook

Individuals in this arm receive a self-guided FAME-W handbook containing the same information as that covered in the four week FAME-W program

Sponsors & Collaborators

  • St. James Hospital

    collaborator UNKNOWN
  • Tallaght University Hospital

    collaborator OTHER
  • Waterford University Hospital

    collaborator UNKNOWN
  • University of Dublin, Trinity College

    lead OTHER

Principal Investigators

  • Deirdre Connolly, PhD · University of Dublin, Trinity College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-28
Primary Completion
2022-09-30
Completion
2023-09-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05138445 on ClinicalTrials.gov