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

NCT ID: NCT05138445

Last Updated: 2021-12-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2023-09-30

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.

Detailed Description

Rheumatic diseases (RD) include over 100 different types of arthritis, the most frequently occurring being Rheumatoid Arthritis, Osteoarthritis, Scleroderma, Systemic Lupus erythmatosus and ankylsoing Spondylitis. However, Inflammatory Arthritis (IA) are one of the most common causes of work disability and despite improvements in medical management of IA, up to 50% of people with IA report workplace difficulties resulting in sick leave, absenteeism and reduced productivity.

This study builds on existing research investigating the impact of IA on work performance of individuals. These earlier studies examined how symptoms of fatigue, pain and stress impact on work capacity of individuals with IA. Based on the findings of these studies a self-management program, FAtigue Management Education for Work (FAME-W) was designed to reduce the impact of fatigue, pain and stress on work performance of individuals with IA. Pilot testing of FAME-W, with a non-experimental design, showed improvements in fatigue, work performance, pain and mood following participation in FAME-W. The proposed study will build on this research by testing the effectiveness of FAME-W as a work-focused self-management intervention to increase work performance of individuals with IA.

Project Design and Methodology

Study Aim

The purpose of this study is to test the effectiveness and acceptability of FAME-W to manage the physical, mental and social demands of work of individuals with IA.

Study Objectives

• To test the effectiveness of FAME-W in reducing the impact of fatigue, pain and stress on work performance of individuals with Inflammatory Arthritis.
• To test the effectiveness of FAME-W in improving work ability of individuals with Inflammatory Arthritis
• To explore the acceptability of FAME-W as a work-based self-management intervention for individuals with Inflammatory Arthritis

Study Design

The study methodology will follow the United Kingdom Medical Research Council (MRC) framework for evaluating complex interventions. A complex intervention consists of a number of interacting components such as those included in the FAME-W intervention. The MRC framework recommends collecting quantitative and qualitative data when evaluating complex interventions. This study will therefore use a sequential exploratory mixed methods design.

The quantitative phase will be a pragmatic randomized control trial (RCT) to test the effectiveness of FAME-W as a work focused self-management intervention to improve individuals' ability to manage their work demands. The CONSORT guidelines for the design and reporting of RCTs will be used at all stages from recruitment, randomization, data collection, analysis and reporting. For the purposes of the proposed study, participants will be randomly allocated to either the group based FAME-W intervention or to a handbook only group. Participants randomized to the group-based FAME-W group will attend an online four-week FAME-W program. The participants in handbook only group will be given a self-guided FAME-W handbook.

The qualitative phase will use a Qualitative Descriptive (QD) design to explore participants' experiences and acceptability of FAME-W. QD is frequently used in health research to evaluate the acceptability and sustainability of health-related interventions. It is considered an appropriate methodology for needs assessments and for informing the planning and delivery of clinical interventions.

Sample Size

Based on the previous studies the individual scores for Work Role Functioning (WRF) questionnaire this study is powered for an effect size of 0.7. To detect an 0.7, 100 participants are required (50 for the group intervention and 50 for handbook only group) to show significance at 5% level, 80% power. Participants will be recruited in groups of 12-14 and then allocated to the intervention or control group using random allocation software.

Data collection methods

Quantitative Data:

Patient Reported Outcome Measures (PROMS, outlined below) will be used to collect quantitative data

Qualitative phase: Qualitative data will be collected from individual interviews and focus groups.

Data collection will be carried out immediately before FAME-W commences, immediately following completion of FAME-W, and 3 months following completion of the program.

Data analysis Quantitative data: Baseline characteristics will be analyzed using descriptive statistics. Multilevel linear regression will be used to examine differences between groups for the primary and secondary outcome measures. Statistical significance at p<0.05 will be assumed throughout.

Qualitative data: Semi-structured interviews will be audio-taped and transcribed. Data analysis will be guided by Braun and Clarke's seven stage thematic analysis of qualitative data.

Conditions

Inflammatory Arthritis

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: FAME-W intervention

Four-week self-management education programme

Group Type: EXPERIMENTAL

FAME-W self-management intervention

Intervention Type: 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 2: FAME-W handbook

Self-guided FAME-W handbook

Group Type: ACTIVE_COMPARATOR

FAME-W Handbook

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. James Hospital

UNKNOWN

Sponsor Role: collaborator

Tallaght University Hospital

OTHER

Sponsor Role: collaborator

Waterford University Hospital

UNKNOWN

Sponsor Role: collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role: lead

Responsible Party

Deirdre Connolly

Professor Deirdre Connolly

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deirdre Connolly, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Dublin, Trinity College

Locations

Trinity College Dublin

Dublin, Leinster, Ireland

Site Status: RECRUITING

Countries

Ireland

Central Contacts

Deirdre Connolly, PhD

Role: CONTACT

Phone: +35318963216

Email: connoldm@tcd.ie

Facility Contacts

Deirdre Connolly, PhD

Role: primary

Shalaleh Karkon, MSc

Role: backup

References

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.

Reference Type: DERIVED

PMID: 37937322 (View on PubMed)

Other Identifiers

UDublinOT

Identifier Type: -

Identifier Source: org_study_id