NCT03825770: Fatigue-HD

Pilot Study of an Educational Program for Adults on Hemodialysis With Fatigue

Completed NA Last updated 29 April 2021

What this trial tests

NA trial testing The "PEP" (Personal Energy Planning) Program in Renal Dialysis in 31 participants. Completed in 15 February 2020.

Timeline

21 February 2019

Primary endpoint
15 February 2020

15 February 2020

Quick facts

Lead sponsor	University of Calgary
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	31
Start date	21 February 2019
Primary completion	15 February 2020
Estimated completion	15 February 2020
Sites	1 location across Canada

Drugs / interventions tested

• The "PEP" (Personal Energy Planning) Program
• General Education about Kidney Disease

Conditions studied

• Renal Dialysis — all drugs for Renal Dialysis →
• Fatigue — all drugs for Fatigue →
• Rehabilitation — all drugs for Rehabilitation →
• Quality of Life — all drugs for Quality of Life →

Sponsor

University of Calgary

Who can join

18 and older, any sex, with Renal Dialysis or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for fatigue in people with kidney failure requiring dialysis.
   Natale P, Ju A, Strippoli GF, Craig JC, et al · · 2023 · cited 16× · PMID 37651553 · DOI 10.1002/14651858.cd013074.pub2
2. A pilot randomised controlled trial of an energy management programme for adults on maintenance haemodialysis: the fatigue-HD study.
   Farragher JF, Ravani P, Manns B, Elliott M, et al · · 2022 · cited 10× · PMID 35144947 · DOI 10.1136/bmjopen-2021-051475
3. A Proof-of-Concept Investigation of an Energy Management Education Program to Improve Fatigue and Life Participation in Adults on Chronic Dialysis.
   Farragher JF, Polatajko HJ, McEwen S, Jassal SV. · · 2020 · cited 9× · PMID 32328286 · DOI 10.1177/2054358120916297
4. Occupational Priorities of People on Hemodialysis Who Participated in Energy Management Education.
   Farragher J, Davis JA, Thomas C, Ravani P, et al · · 2025 · cited 1× · PMID 39113490 · DOI 10.1177/00084174241271205