Managing Fatigue in People With Parkinson's Disease

NCT04267107 | Completed

• 1 other identifier: 2019-4954
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to evaluate the feasibility of Managing Fatigue: The Individual Program (MFIP) in people living with Parkinson's disease. The Managing Fatigue Program, a six-week, self-management energy conservation course, focuses on strategies that help people with fatigue to make changes to save and use their energy to accomplish their daily activities. Several studies have adapted and evaluated different delivery formats of the program in conditions similar to Parkinson's disease, demonstrating that the Managing Fatigue Program is effective in reducing fatigue impact, depression, sleep problems, and improving quality of life, participation and self-efficacy. While this program has been tested in people living with many chronic conditions there has been only limited inclusion of people living with PD. This feasibility study, using a mixed-methods approach, nested in a pilot randomized control design, will evaluate the feasibility of the Individual Managing Fatigue Program from the perspectives of people with Parkinson's disease, and prepare for a full-scale randomized controlled trial (RCT). In this study, Managing Fatigue: The Individual Program (MFIP) will be delivered using videoconferencing. This feasibility study will use a mixed-methods approach, nested in a pilot two-armed randomized controlled design. Using a concurrent mixed-method design, we will collect two types of data (qualitative and quantitative) simultaneously, expanding our understanding of the feasibility of the program. Data will be collected using feasibility questionnaires developed by the research team, standard outcome measures, and group discussions. Multiple recruitment strategies will be used to recruit a convenience sample of 50 participants (25 in each group) from across the province of Nova Scotia, Canada. Eligible participants will be randomly assigned to either the control or experimental group using sealed envelopes. The study outcome measures will be administered three times during the study; pre-test, post-test after 6 weeks, and at three-month follow-up. The results of this study will determine whether it is feasible to do a full-scale RCT in the future. If the known beneficial effects of the Managing Fatigue program extend to the PD population, this research will be the evidence needed to support the integration of this novel solution into the care of people with PD.

Conditions

Parkinson Disease

Keywords

Parkinsons disease; Self-management; Fatigue management; Occupational therapy

Outcome Measures

Primary Outcomes (6)

• Multidimensional Fatigue Inventory (MFI)

  Fatigue impact will be measured with the Multidimensional Fatigue Inventory (MFI) (Smets et al., 1995). The MFI is a self-report fatigue tool with 20 items measuring five dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motion, and Reduced Activity. Elbers and colleagues (2012) evaluated the MFI in the PD population (N=153). After combining General Fatigue and Physical Fatigue dimensions they reported the reliability and validity of the four-domain scale (Physical Fatigue, Mental Fatigue, Reduced Motivation, and reduced activity) as higher than the original five-domain scale. Testing of the MFI shows good internal consistency (Cronbach's alpha \>0.80) and construct validity compared to a Visual Analogue Scale measuring fatigue (0.22\<r\<0.78) (Smets et al., 1995).

  Changes from baseline fatigue impact to six weeks later at post-test, and after a three-month follow up.

• Occupational Balance Questionnaire

  Occupational balance will be measured with the Occupational Balance Questionnaire (OBQ) (Wagman \& Håkansson, 2014). The OBQ is an 11-item measure developed by Wagman et al., (2014), which assesses individuals' satisfaction and perception with the amount and variation of meaningful occupations. The OBQ measures satisfaction with the amount of time that one takes to accomplish tasks. It uses a 4-level ordinal response scale for each item ranging from 0 "completely disagree" to 3 "completely agree". The OBQ total score ranges from 0 (no occupational balance) to 35 (maximum occupational balance). The psychometric properties of the OBQ have not been explored in PD. However, in the general population, it has shown good internal consistency (Cronbach's alpha= 0.936) and test, re-test reliability (Spearman's Rho= 0.926) for its total score (N=67). Neither ceiling nor floor effects were reported (Håkansson, Wagman, \& Hagell, 2019).

  Changes from baseline occupational balance to six weeks later, at post-test, and after a three-month follow up.

• Canadian Occupational Performance Measure

  Occupational performance will be measured with the Canadian Occupational Performance Measure (COPM) (Law, M. Baptiste, S., Carswell, A. McColl, M. A., Polatajko, H. \& Pollock, 1998). The COPM was selected since it has proven to be sensitive to change and was able to detect significant differences between study groups at three months (mean difference =1.2 (95% CI 0.8-1.6) and after 6 months follow-up (mean differences= 0.9 ( 95%CI 0.5-1.3) (I. Sturkenboom et al., 2013). The COPM is a client-centred, standardized, cost-effective, occupation-focused measure used in occupational therapy. It is an individualized outcome measure administered using a semi-structured interview. It measures occupational performance and occupational satisfaction (Law, M. Baptiste, S., Carswell, A. McColl, M. A., Polatajko, H. \& Pollock, 1998).

  Changes from baseline occupational performance to six weeks later, at post-test, and after a three-month follow up.

• Parkinson's Disease Quality of Life-8 (PDQ-8)

  Quality of life will be measured with the Parkinson's Disease Quality of Life-8 (PDQ-8) (Tan et al., 2004). The PDQ-8 is a short-form version of the Parkinson Disease Questionaire-39 which assesses the impact of PD on HRQoL over the past month. The PDQ-8 is a summary index with eight items, each representing one dimension of the PDQ-39 (Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort). It uses a 0-4 response scale. Scores are summed, then converted into a percentage. Lower scores indicate better quality of life (Peto et al., 1995). The PDQ-8 psychometric properties have been confirmed in several studies (Franchignoni, Giordano, \& Ferriero, 2008; Katsarou et al., 2004; Luo et al., 2009; Tan, Luo, Nazri, Li, \& Thumboo, 2004). Franchignon et al (2008) and Tan et al (2004) demonstrated good internal consistency (Cronbach's alpha 0.72, 0.81) and construct validity between PDQ-8 and a measure of autonomy and

  Changes from baseline quality of life to six weeks later, at post-test, and after a three-month follow up.

• Pittsburgh Sleep Quality Index (PSQI)

  Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al., 1989). PSQI is the most common assessment tool used to evaluate sleep quality (Mollayeva et al., 2016). It is a 19-item self-report assessment that measures seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989). Component scores range from 0 (no difficulty) to 3 (severe difficulty) and are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A meta-analysis by Mollayeva et al. (2016) evaluated the measurement properties of the PSQI. This meta-analysis (N=37) demonstrated that the PSQI has good internal consistency based on Cronbach's alpha, strong reliability and validity, and moderate structural validity in a variety of samples. The PSQI has been used as an outcome measure to test the effectiveness

  Changes from baseline sleep quality to six weeks later, at post-test, and after a three-month follow up.

• Self Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)

  The Self-efficacy will be measured by the Self Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA) (Liepold \& Mathiowetz, 2005). The SEPECSA was developed based on the Managing Fatigue Program (Liepold \& Mathiowetz, 2005) and measures the individual's self-confidence to perform the strategies they learned in the program. The item response scale of the SEPECSA ranges from 1 (not at all confident) to 10 (completely confident). The final score is mean of the item scores. In a study of individuals with MS (N=36), Liepold \& Mathiowetz (2005) demonstrated that the SEPECSA has high test and retest reliability (r = .776, ICC = .771), good validity, and very high internal consistency (Cronbach's alpha = .953). The SPECSA has not been used with the PD population, however, it has been used in previous similar studies (Ghahari et al., 2010; Matuska, Mathiowetz, \& Finlayson, 2007).

  Changes from baseline self-efficacy to six weeks later, at post-test, and after a three-month follow up.

Other Outcomes (3)

• Relevance, acceptability, and usability of each session of the Individual Managing Fatigue Program

  After each weekly session

• Relevance, acceptability, and usability of the Individual Managing Fatigue Program

  After six weeks at post test

• Socio-Demographic Questionnaire.

  At baseline

Study Arms (2)

Managing Fatigue:The Individual Program

EXPERIMENTAL

Participants in the experimental group will receive the 6-week MFIP. Individuals in experimental group : * will participate in six one-to-one sessions (each takes 60 to 90 minutes) * will complete the Feasibility Questionnaire #1, after each session (10 questions) (Appendix 6) * will complete Feasibility Questionnaire #2 after completing all six-sessions (12 questions) (Appendix 7) * will complete the post-test measurement after completion of the program (approximately 60 minutes to complete) * will complete the follow-up measurement, three months after the completion of the program (approximately 60 minutes to complete) * will be advised to continue with their current healthcare services. * may participate in one focus group (one-hour session)

Other: Individual Managing Fatigue Program

Control Group

NO INTERVENTION

Participants in the control group will not receive the IMFP and they will be advised to continue with their current healthcare services. Participants in the control group: * will complete post-test measurements after 6 weeks (approximately 60 minutes), * will complete the follow-up measurements three months later after completing the program (approximately 60 minutes). * will be advised to continue with their current healthcare services. Following the study, participants in the control group will be offered the manual of the program and a three-hour training workshop after (three months after the baseline testing). In this workshop, they will learn about the about the program, including the pre-session activities, in-session activities, and homework. This workshop will be conducted by occupational therapists.

Interventions

Individual Managing Fatigue Program OTHER

The Individual Managing Fatigue Program includes six weekly sessions that focus on sleep, communication and body mechanics, activity stations, priorities and standards, and balancing daily schedule. Each session includes three parts: 1) a pre-session activity 2) in-session activities/information and 3) homework. Prior to coming to each session, participants will be asked to complete activities that will help them prepare for the in-session discussions. During each session participants will discuss and practice the topics most important to them. Based on their discussions, participants and therapists will decide on activities to complete during each session and as homework. The therapist will help the participant begin the homework at the end of each session, and the participant will finish it outside of the session at home. At the beginning of the following session, the therapist and participant will review the homework.

Also known as: Energy conservation, Self-management, Occupational therapy

Managing Fatigue:The Individual Program

Eligibility Criteria

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

You may qualify if:

• All participants must:
• Be adults living in Nova Scotia,
• Self-report Parkinson's disease, and fatigue severe enough to interfere with daily life (measured by a score of ≥4 on the FSS).
• Read and speak in English
• Have access to the internet, an electronic device and a private place for Zoom videoconferences.
• Provide informed consent prior to participation.

You may not qualify if:

• People will be excluded from the study if :
• They have previously completed the study program (IMFP )
• They have co-morbidity that causes severe fatigue (e.g. heart failure, cancer)
• They indicate a severe cognitive deficit in the MMSE test ( MMSE \<13).

Sponsors & Collaborators

• Dalhousie University: lead

Study Sites (1)

Dalhousie University

Halifax, NovaScotia, B3H4R2, Canada

Location

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  BACKGROUND

• Alizadeh N, Packer TL, Jaswal S, Sturkenboom I, Warner G. Client Perceptions of the Individual Packer Managing Fatigue Program: A Mixed-Method Evaluation. OTJR (Thorofare N J). 2024 Oct;44(4):632-641. doi: 10.1177/15394492241262740. Epub 2024 Jul 31.

  PMID: 39086144 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Conservation of Energy Resources; Self-Management; Occupational Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Conservation of Natural Resources; Environment; Environment and Public Health; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Tanya Packer, PhD

  Dalhousie University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants cannot be masked to study groups in this study. The researcher who is responsible for data collection and data analysis will be masked to group allocation. A research assistant will assign ID codes to each participant, manage the key to the ID codes. Feasibility questionnaire, only for experimental group, will be coded with participant ID codes. Participants will be instructed not to share any information on group allocation with the researcher during the assessments. Masking of the assessor will be monitored by reports of the assessor receiving any information during the assessments on the allocation of the participant. If there are multiple occurrences of this, a sensitivity analysis will be used.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Tanya Packer, Professor, School of Occupational Therapy

Model Details: This feasibility study will use a mixed-methods approach, nested in a pilot 2-arm randomized control design (experimental and no intervention control). We will collect qualitative and quantitative data simultaneously which will expand our understanding of the feasibility of the program.

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 12, 2020
• Study Start: November 2, 2020
• Primary Completion: July 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)