Pilot Study of an Educational Program for Adults on Hemodialysis With Fatigue (Fatigue-HD)
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|ClinicalTrials.gov Identifier: NCT03825770|
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : April 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Renal Dialysis Fatigue Rehabilitation Quality of Life Kidney Diseases||Behavioral: The "PEP" (Personal Energy Planning) Program Behavioral: General Education about Kidney Disease||Not Applicable|
BACKGROUND: Fatigue is one of the most common, disabling, and distressing symptoms experienced by people with end-stage renal disease (ESRD; kidney failure). There are currently few evidence-based treatment options to address fatigue in the ESRD population. Energy conservation education (ECE) is a rehabilitative approach shown to improve fatigue-related outcomes in other chronic disease populations, that has yet to be studied in people with ESRD. The investigators recently developed a novel ECE program for people with ESRD, conducted acceptability and usability testing, and showed improvements in fatigue and disability in single-case studies. A large randomized controlled trial (RCT) is now required to establish the efficacy of the PEP program, but additional feasibility information is first needed to design the definitive RCT.
- To estimate the proportion of ESRD patients that are eligible for the RCT, will consent to participate, and will complete all study procedures
- To identify the optimal primary outcome for the RCT and estimate the treatment effect size for RCT sample size calculations
- To examine treatment fidelity to the PEP program among non-rehabilitation staff who undergo program administration training
- To explore the effects of the PEP program on fatigue and disability at 3 months post-treatment
METHODS: Single-center, 1:1, parallel-arm pilot RCT. Adults on hemodialysis in Calgary at 4 dialysis units will be screened for eligibility. Prospective participants will be identified and approached by a clinical team member to assess their interest in the study. Interested patients will then be approached by a research team member to undergo informed consent and eligibility screening. Consenting participants will be randomized using a computer-generated randomization list and blocked randomization. Patients and outcome adjudicators will be blinded as to which is the treatment vs. control condition (blinding of providers is not feasible). Participants randomized to intervention will undergo the PEP energy conservation education program, consisting of two web modules and 4-7 sessions with a study clinician. Participants randomized to control will review the "Living with Kidney Disease" patient handbooks with a study clinician. Routine demographic and clinical data will be obtained at baseline, and the following measures will be administered to participants at baseline, mid-treatment, immediate post-treatment, and three months post-treatment: the Fatigue Severity Scale, Fatigue Impact Scale, Fatigue Management Questionnaire, Reintegration to Normal Living Index, and Canadian Occupational Performance Measure. A sample size of 40 patients (20 per arm) will provide an optimal estimate of treatment effect size for RCT sample size calculations, given 80% power, a small/medium effect size, and an attrition rate of ≤20%.
DATA ANALYSIS: The proportion of patients meeting each of the feasibility endpoints (eligibility, recruitment and attrition rates) will be calculated. Pre-to-post effect sizes will be calculated for all outcome measures used, and the outcome measure with the largest effect size will be chosen as the primary outcome for the RCT. Sample size calculations will then be made using the treatment effect size and variance from the pilot RCT data. Audio recordings of treatment sessions will be reviewed and rated using a Likert-scale rating system to estimate treatment fidelity. Effect sizes will also be calculated from pre-intervention to 3 months post-intervention.
IMPLICATIONS: Findings from this pilot RCT will help in the design of a robust RCT of the PEP program, which has the potential to improve fatigue management in the ESRD population.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 pilot randomized controlled trial. Participants will be randomized to intervention (energy conservation education) or active control (general information about kidney disease).|
|Masking Description:||Study participants will be blinded as to which educational program is the "active" treatment under study. Patient study materials and communications will only describe the study as being about an educational program for adults on hemodialysis with fatigue.|
|Official Title:||A Pilot Randomized Controlled Trial of an Educational Program for Adults on Hemodialysis With Fatigue|
|Actual Study Start Date :||February 21, 2019|
|Actual Primary Completion Date :||February 15, 2020|
|Actual Study Completion Date :||February 15, 2020|
Experimental: The "PEP" Program
The "PEP" (Personal Energy Planning) Program
Behavioral: The "PEP" (Personal Energy Planning) Program
The PEP program is designed to teach people on dialysis with fatigue how to conserve energy during day-to-day tasks, and how to use energy conservation to accomplish their goals. The program is delivered over 7-9 weekly sessions. It consists of 2 educational web modules about energy conservation, and 5-7 goal-focused training sessions with a study clinician that utilize a problem-solving training approach known as the Cognitive Orientation to Occupational Performance (CO-OP) approach. Each program session lasts ~20-30 mins. Sessions are completed either in person during hemodialysis, or via telephone (based on patient preference). The program is administered by a trained study clinician (occupational therapist or nurse).
Active Comparator: General Education
General Education about Kidney Disease
Behavioral: General Education about Kidney Disease
General education about kidney disease involves a review of information from the Kidney Foundation of Canada's patient handbooks "Living with Reduced Kidney Function" and "Living with Kidney Failure" (www.kidney.ca/manual) during 6-8 brief individual sessions with a trained study clinician (occupational therapist or nurse).The handbooks contains general information about managing kidney disease, addressing topics such as medication management, diet, and emotional well-being on dialysis. Sessions will take place either in person during hemodialysis, or via telephone (based on patient preference).
- Eligibility rate [ Time Frame: From start to end of study screening (approximately 9 months) ]The proportion of patients screened who are eligible for the study
- Recruitment rate [ Time Frame: From start to end of study recruitment (approximately 9 months) ]The proportion of patients eligible for the study who consent to participate
- Attrition rate [ Time Frame: From start to end of study data collection (approximately 15 months) ]The proportion of consenting patients who withdraw from the study before completing all study activities
- Fatigue Severity Scale [ Time Frame: From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention ]A 9-item self-report questionnaire which measures the severity of fatigue and its impact on activities and lifestyle
- Fatigue Impact Scale [ Time Frame: From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention ]A 21-item self-report questionnaire which assesses the effects of fatigue on physical, cognitive, and psychosocial functioning
- Fatigue Management Questionnaire [ Time Frame: From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention ]A 5-item self-report questionnaire which assesses self-perceived competence at fatigue management
- Reintegration to Normal Living Index [ Time Frame: From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention ]An 11-item self-report questionnaire which assesses the degree to which individuals who have experienced traumatic or incapacitating illness, achieve reintegration into normal social activities
- Canadian Occupational Performance Measure [ Time Frame: From 2 weeks mid-intervention to 1 week post-intervention, and 3 months post-intervention ]An outcome measure designed to capture a client's self-perception of performance in everyday living, over time
- Fidelity to treatment protocol [ Time Frame: From start to end of study intervention (approximately 10 weeks per participant) ]Adherence to PEP program protocol by program administrators, measured by the Co-op Fidelity Checklist
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825770
|South Calgary Health Centre|
|Calgary, Alberta, Canada, T2X 3W5|
|Principal Investigator:||Brenda R Hemmelgarn, MD, PhD||University of Calgary|