Clinical trial NCT05138445: Effectiveness of Fatigue and Activity Management in Work (FAME-W) for Individuals With Inflammatory Arthritis
Official title: Testing the Effectiveness of Fatigue and Activity Management in Work (FAME-W) Self-management Intervention for Individuals With Inflammatory Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Arthritis
Keywords: Work disability
Self-management
Fatigue management
Occupational Therapy
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: St. James Hospital
name: Tallaght University Hospital
name: Waterford University Hospital
First posted: 2021-12-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Work Role Functioning Questionnaire
timeFrame: Three months
Secondary outcomes:
measure: Euro QoL 5 Dimensions -5 levels (5D-5L)
timeFrame: Three months
measure: Multidimensional Fatigue Inventory
timeFrame: Three months
measure: Arthritis Work Spillover
timeFrame: Three months
measure: Hospital Anxiety and Depression scale (HADS)
timeFrame: Three months
measure: The Stanford Arthritis Self-Efficacy Scale Short Form
timeFrame: Three months
measure: The Arthritis Impact Measurement Scale
timeFrame: Three months
measure: The Short Form McGill Pain Questionnaire
timeFrame: Three months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Trinity College Dublin
state: Leinster
Study officials:
affiliation: University of Dublin, Trinity College
name: Deirdre Connolly, PhD
role: PRINCIPAL_INVESTIGATOR
References: