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

NCT05138445 | Unknown

• 1 other identifier: UDublinOT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Work disability; Self-management; Fatigue management; Occupational Therapy

Outcome Measures

Primary Outcomes (1)

• Work Role Functioning Questionnaire

  Work Role Functioning questionnaire is a 27-self-report questionnaire that measures an individual's ability to meet demands of five categories of work: scheduling, output, psychical, mental and social demands. All 27 items are scored on a five point scale, with a score of four given for the response 'difficult none of the time' and a score of zero representing 'difficult all of the time'. Each of the five sub-scales are scored separately. A score is established by adding the response of each item, calculating the average and multiplying this by 25 to achieve an overall percentage. The overall percent can range from 0% (difficult all of the time), to 100% (never difficult) meeting the demands of the job.

  Three months

Secondary Outcomes (7)

• Euro QoL 5 Dimensions -5 levels (5D-5L)

  Three months

• Multidimensional Fatigue Inventory

  Three months

• Arthritis Work Spillover

  Three months

• Hospital Anxiety and Depression scale (HADS)

  Three months

• The Stanford Arthritis Self-Efficacy Scale Short Form

  Three months

Study Arms (2)

Arm 1: FAME-W intervention

EXPERIMENTAL

Four-week self-management education programme

Behavioral: FAME-W self-management intervention

Arm 2: FAME-W handbook

ACTIVE COMPARATOR

Self-guided FAME-W handbook

Behavioral: FAME-W Handbook

Interventions

FAME-W self-management intervention BEHAVIORAL

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.

Arm 1: FAME-W intervention

FAME-W Handbook BEHAVIORAL

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

Arm 2: FAME-W handbook

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of Inflammatory Arthritis,
• In full-time or part-time employment
• Must be able to provide informed consent,
• Must be able to participate in a four-week group-based self-management intervention
• Must have access to an electronic device and stable internet access

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• St. James Hospital: collaborator
• Tallaght University Hospital: collaborator
• Waterford University Hospital: collaborator

Study Sites (1)

Trinity College Dublin

Dublin, Leinster, D08 EF20, Ireland

RECRUITING

Related Publications (1)

• Karkon S, Bennett KE, O'Shea F, Doran M, Connolly D. Testing the effectiveness of a Fatigue and Activity Management Education for Work (FAME-W) intervention for individuals with inflammatory arthritis: Study protocol for a randomized control trial. Musculoskeletal Care. 2023 Dec;21(4):1629-1638. doi: 10.1002/msc.1839. Epub 2023 Nov 7.

  PMID: 37937322 DERIVED

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Deirdre Connolly, PhD

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deirdre Connolly, PhD

CONTACT

+35318963216; connoldm@tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Deirdre Connolly

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 1, 2021
• Study Start: January 28, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2023
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for six months following related publications
• Access Criteria: Requests for data sharing can be made to the study central contact person via email.

Locations

IE (1)