Clinical trial NCT03825770: Pilot Study of 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Dialysis
Fatigue
Rehabilitation
Quality of Life
Kidney Diseases
Keywords: Fatigue
Energy conservation
Rehabilitation
Occupational therapy
End-stage renal disease
Chronic kidney disease
Hemodialysis
Disability
Quality of life
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

Brief summary: Fatigue is a common and problematic symptom of end-stage renal disease (ESRD). The investigators have developed a new program, called the Personal Energy Planning (PEP) program, that teaches people with ESRD to manage fatigue by using energy conservation strategies during everyday life (eg. organization, prioritization, using good body postures and assistive tools). A large study is needed to test whether the program is helpful for people with ESRD. First, the investigators need to do a smaller-scale pilot study to help plan the large study. The main purposes of this pilot study are to see how many people with ESRD are willing and able to complete the PEP program, and to explore whether the program helps people feel less fatigued. The investigators plan to invite 40 people with ESRD from 4 dialysis units in Calgary, Alberta to participate. People with ESRD who report feeling unusually tired a lot of the time (using a symptom assessment tool completed every 2 months) will be asked to take part. Study participants will either do the PEP program, or another program (the control) that gives them general information about kidney disease. Participants will also be asked to complete questionnaires about fatigue before and after the study. The investigators will compare fatigue scores between the PEP program group and the control group, and record how many agree to take part in the study and complete all study activities. This pilot study will help the investigators plan next steps for research into the PEP program.

Detailed description: 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.

OBJECTIVES:

1. To estimate the proportion of ESRD patients that are eligible for the RCT, will consent to participate, and will complete all study procedures
2. To identify the optimal primary outcome for the RCT and estimate the treatment effect size for RCT sample size calculations
3. To examine treatment fidelity to the PEP program among non-rehabilitation staff who undergo program administration training
4. 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.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years
* On chronic dialysis therapy for ≥3 months at time of recruitment
* Clinically and cognitively stable (able to provide informed consent)
* Scores an avg. of ≥4 on items 5, 7 , 8 and 9 of the Fatigue Severity Scale

Exclusion Criteria:

* Inadequate written and verbal English comprehension for study activities
* Plan in place to discontinue in-center hemodialysis at the participating center within 6 months of the time of recruitment (due to modality change, relocation, transplantation, or dialysis withdrawal)
* Resides in a nursing home facility
* Significant visual impairment (ie. unable to read size 14-pt font, Times New Roman)
* Scores \>3 on Personal Health Questionnaire 2 (PHQ-2) depression screening tool

Primary outcomes:
measure: Eligibility rate
timeFrame: From start to end of study screening (approximately 9 months)
measure: Recruitment rate
timeFrame: From start to end of study recruitment (approximately 9 months)
measure: Attrition rate
timeFrame: From start to end of study data collection (approximately 15 months)
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention
measure: Fatigue Impact Scale
timeFrame: From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention
measure: Fatigue Management Questionnaire
timeFrame: From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention
measure: Reintegration to Normal Living Index
timeFrame: From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention
measure: Canadian Occupational Performance Measure
timeFrame: From 2 weeks mid-intervention to 1 week post-intervention, and 3 months post-intervention
Other outcomes:
measure: Fidelity to treatment protocol
timeFrame: From start to end of study intervention (approximately 10 weeks per participant)
Locations:
city: Calgary
country: Canada
facility: South Calgary Health Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Brenda R Hemmelgarn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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