Managing Fatigue: The Individual Program in People Living With Parkinson's Disease- A Protocol for a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Multidimensional Fatigue Inventory (MFI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Multidimensional Fatigue Inventory (MFI)
时间窗: Changes from baseline fatigue impact to six weeks later at post-test, and after a three-month follow up.
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).
Canadian Occupational Performance Measure
时间窗: Changes from baseline occupational performance to six weeks later, at post-test, and after a three-month follow up.
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).
Occupational Balance Questionnaire
时间窗: Changes from baseline occupational balance to six weeks later, at post-test, and after a three-month follow up.
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).
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Changes from baseline sleep quality to six weeks later, at post-test, and after a three-month follow up.
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
Self Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)
时间窗: Changes from baseline self-efficacy to six weeks later, at post-test, and after a three-month follow up.
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).
Parkinson's Disease Quality of Life-8 (PDQ-8)
时间窗: Changes from baseline quality of life to six weeks later, at post-test, and after a three-month follow up.
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
次要结局
未报告次要终点
研究者
Tanya Packer
Dr.Tanya Packer, Professor, School of Occupational Therapy
Dalhousie University