Clinical trial NCT04267107: Managing Fatigue in People With Parkinson's Disease
Official title: Managing Fatigue: The Individual Program in People Living With Parkinson's Disease- A Protocol for a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinsons disease
Self-management
Fatigue management
Occupational therapy
Lead sponsor: Dalhousie University
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The aims of this study are to:

Aim 1. Evaluate the feasibility of the IMFP protocol in people living with PD. The sub-aims are to evaluate: (a) the relevance, acceptability, and perceived impact of the content of the MFIP from the perspective of recipients; and (b) the acceptability of the delivery logistics (technology, time, duration) of the MFIP from the perspective of individuals with PD.

Aim 2. Prepare for a full-scale RCT. The sub-aims are to (a) explore the preliminary effectiveness of the MFIP, (b) assess the suitability of the trial recruitment strategy based on the enrolment, completion and attrition rates, and variation in socio-demographic features of participants; (c) evaluate the suitability of potential outcome measures; and (d) use data arising from differences in the study outcomes between the MFIP and control arms to inform a power calculation for the sample size of a definitive RCT. As this study is a feasibility study, there is no primary versus secondary outcomes. The outcomes for this study are occupational performance, occupational balance, fatigue impact, quality of life, sleep quality and self-efficacy.

Sample Size Calculation: As a pilot study, a power calculation is not strictly required. However, in preparation for the current study, investigators conducted both a sample size calculation and consulted previous literature to inform our estimation. To calculate the sample size, the type-1 error was set at 5% and the type-2 error was set at 20% for a power of 80%. Effect sizes were taken from available studies as follows: for the MFI, the effect size of -0.664 and for the COPM the effect size of 0.37. The results indicate that a total sample size of 42 participants will be required using the minimum effect size for the COPM. Estimating an attrition rate of 20%, a convenience sample of 50 participants (25 in each group) will be recruited from across the Halifax Regional Municipality (HRM), Canada.

This sample size selection aligns with recommendations for pilot studies by other researchers who have suggested that a minimum sample size of 24 to 50 is required for pilot feasibility studies. In another study by Hertzog (2008), a minimum sample of 10-25 people per group for feasibility studies is recommended.

Recruitment: Individuals for this study will be recruited in several different ways across the province of Nova Scotia. Investigators will recruit using 1) web-based advertisements on the International Chronic and Complex Conditions Research Group website and KIJIJI, 2) posters at the Parkinson's Society Maritime Region office 3) social media (Twitter, Facebook), 4) public TV advertising and 5) word of mouth. Individuals who are interested in participating in the study will contact the research team.

Individuals who are interested in participating will be invited to contact the research team by email. Potential participants will first undergo an email screening procedure to confirm preliminary eligibility criteria. Once eligibility is confirmed they will be sent study information and a consent form by email. Final eligibility will be confirmed after completion of the FSS and the MMSE during a videoconference call. Consent will be ascertained and confirmed verbally prior to any data collection. Participants will be informed that they may withdraw from the study at any time and for any reason. The assessor for all screening and data collection will be blind to group allocation.

Data Collection-Aim 1: This aim will be achieved using data collected from only the experimental group.

Registered occupational therapists will deliver the IMFP. Therapists graduate with the knowledge and skills to treat people with neurological conditions. All therapists will be required to successfully complete an online training session prior to participation. They will learn about the MFIP and the current evidence-based guidelines and research about working with individuals with PD.

The therapists will be instructed to report to the study supervisor and the principal researcher if there are any safety complications during the sessions.

Feasibility Questionnaires (experimental group only): Two feasibility questionnaires, based on the purposes of the study and the program's intentions, will be administered to participants. Questionnaire # 1 will evaluate the relevance, acceptability, and usability of each session. Participants will complete these, online, after each weekly session. Questionnaire #2 will evaluate the relevance, acceptability, usability, and logistical aspects of the whole program. It will be administered once, at the completion of the program. The responses on the feasibility questionnaires use a five-point Likert scale (Likert, 1932) (0 = 'strongly disagree' to 4 = 'strongly agree). A research assistant, independent from other parts of the study, will send the individualized links for each questionnaire to participants by email. Data collected on the Feasibility Questionnaires will be cleaned and analyzed at the completion of all data collection. This will ensure that this researcher remains masked to group allocation during the study data collection.

Focus Groups: After completion of the program, 15 participants will be recruited to participate in one of three focus groups (n=5) using maximum variation sampling based on disease duration, fatigue severity, and gender. Participants will provide separate consent prior to participating. An experienced, independent research assistant will conduct the focus groups via videoconference using a prepared interview guide. Participants will be encouraged to discuss the feasibility of the program (relevance, usability, acceptability, and logistics), barriers to completion of the program, acceptability of study measures, and any perceived impact/changes (improvements/adverse events).

Data collection - Aim 2: To evaluate the preliminary effectiveness of MFIP in people living with PD and the feasibility of potential outcome measures a collection of patient-reported outcome measures will be used. The outcomes for this study are occupational performance, occupational balance, fatigue impact, quality of life, sleep quality and self-efficacy. Effectiveness data will also be used to inform the power calculation for a definitive trial. The study outcome measures will be administered at baseline, at post-intervention and at three months following completion of the program.

The principal researcher, who will be masked to group allocation, will be responsible for administering all the study outcome measures online using the Opinio Survey Software Application while videoconferencing with the researcher.

Data Analysis: All quantitative data in this study will be analysed using STATA software (release 15 for Windows). After data entry, data will be examined for skewness, outliers, and systematic missing data. Extreme outliers, defined as greater than ±2SD from the mean will be removed from the data if they are less than 5% of all data (Allison, 2001)

Data from the feasibility questionnaires will be analyzed using descriptive analysis, including frequencies and proportions for categorical data (e.g. demographic data), and means, and standard deviations for continuous data (e.g. questionnaires).

Using general linear mixed model analysis, the preliminary effectiveness of the program will be determined. This analysis method will account for missing data at the measurement level. Also, in this study, we do not expect missing data at the item-level as all the measurements are completed with the supervision of the principal researcher. If there are missing data, they will be managed using the required steps based on the protocol of each measurement tool. If the maximum number of missing items has not been included in the protocol of measurements it will be set at 20%. If the scoring algorithm does not provide for missing data, values will be imputed using mean substitution.

Using calculated effect sizes, this study will 1) estimate the preliminary effectiveness and the required sample size for future RCTs, and 2) evaluate the sensitivity and responsiveness of the study outcome measures. Measurement tools with the highest effect size and the smallest significance level are the most sensitive measures to change due to the intervention (Corzillius, Fortin, \& Stucki, 1999. In regard to the responsiveness of measures, measurement tools that have higher levels of variability in participants at baseline, in relation to mean change scores, will have a smaller effect and therefore, are less responsive (Husted, Cook, Farewell, \& Gladman, 2000. Qualitative data obtained from participants in focus group, together with the quantitative data will be used to recommend outcome measures for the future RCT.

The efficiency of the recruitment strategies will be examined using data from the number of individuals who contact the research team, the number of participants who meet the study criteria, the number who withdraw from the study or are lost to follow-up (attrition rates), and the variation in sociodemographic characteristics of the participants.

Focus groups will be audiotaped and transcribed verbatim. Any potentially identifying information will be removed prior to analysis. Data will be analyzed using the six-stage content analysis framework by Braun and Clarke (2014). Data will be managed using the NVIVO qualitative data analysis software (QSR International Pty Ltd., Version 11, 2015). The text will be coded without any changes in meaning. Coded material will be categorized semantically until themes emerge. Codes and themes will be reviewed and refined until the final distinctive themes can be created (Bob-Milliar, 2014).

Eligibility criteria: Inclusion Criteria:

All participants must:

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

Exclusion Criteria:

People will be excluded from the study if :

1. They have previously completed the study program (IMFP )
2. They have co-morbidity that causes severe fatigue (e.g. heart failure, cancer)
3. They indicate a severe cognitive deficit in the MMSE test ( MMSE \<13).

Primary outcomes:
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: Changes from baseline fatigue impact to six weeks later at post-test, and after a three-month follow up.
measure: Occupational Balance Questionnaire
timeFrame: Changes from baseline occupational balance to six weeks later, at post-test, and after a three-month follow up.
measure: Canadian Occupational Performance Measure
timeFrame: Changes from baseline occupational performance to six weeks later, at post-test, and after a three-month follow up.
measure: Parkinson's Disease Quality of Life-8 (PDQ-8)
timeFrame: Changes from baseline quality of life to six weeks later, at post-test, and after a three-month follow up.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Changes from baseline sleep quality to six weeks later, at post-test, and after a three-month follow up.
measure: Self Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)
timeFrame: Changes from baseline self-efficacy to six weeks later, at post-test, and after a three-month follow up.
Secondary outcomes:
Other outcomes:
measure: Relevance, acceptability, and usability of each session of the Individual Managing Fatigue Program
timeFrame: After each weekly session
measure: Relevance, acceptability, and usability of the Individual Managing Fatigue Program
timeFrame: After six weeks at post test
measure: Socio-Demographic Questionnaire.
timeFrame: At baseline
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: NovaScotia
Study officials:
affiliation: Dalhousie University
name: Tanya Packer, PhD
role: STUDY_DIRECTOR
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