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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
Sponsor:
Information provided by (Responsible Party):
Dr. Brenda Hemmelgarn, University of Calgary

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
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: Single (Participant)
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Canada, Alberta
South Calgary Health Centre
Calgary, Alberta, Canada, T2X 3W5
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Brenda R Hemmelgarn, MD, PhD University of Calgary
Publications:

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Responsible Party: Dr. Brenda Hemmelgarn, Department Head, Community Health Sciences, University of Calgary
ClinicalTrials.gov Identifier: NCT03825770    
Other Study ID Numbers: 18-1657
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Brenda Hemmelgarn, University of Calgary:
Fatigue
Energy conservation
Rehabilitation
Occupational therapy
End-stage renal disease
Chronic kidney disease
Hemodialysis
Disability
Quality of life
Additional relevant MeSH terms:
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Kidney Diseases
Fatigue
Urologic Diseases