Pilot Study of an Educational Program for Adults on Hemodialysis With Fatigue (Fatigue-HD)

April 27, 2021 updated by: Dr. Brenda Hemmelgarn, University of Calgary

A Pilot Randomized Controlled Trial of an Educational Program for Adults on Hemodialysis With Fatigue

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2X 3W5
        • South Calgary Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From start to end of study screening (approximately 9 months)
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
From start to end of study recruitment (approximately 9 months)
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
From start to end of study data collection (approximately 15 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention
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
From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention
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
From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention
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
From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention
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
From 2 weeks mid-intervention to 1 week post-intervention, and 3 months post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From start to end of study intervention (approximately 10 weeks per participant)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Brenda R Hemmelgarn, MD, PhD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 21, 2019

Primary Completion (ACTUAL)

February 15, 2020

Study Completion (ACTUAL)

February 15, 2020

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (ACTUAL)

January 31, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1657

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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