The Energy Conservation Education Intervention

The Energy Conservation Education Intervention For People With End-stage Kidney Disease Receiving Haemodialysis (EVEREST)

Fatigue is the most common symptom reported by 70 - 85 % of people with end-stage kidney disease (ESKD) receiving haemodialysis (HD). Educational interventions involving energy conservation strategies are helpful in reducing fatigue. However, the effectiveness of energy conservation has not been previously studied in people with ESKD receiving HD. This study aims to develop and evaluate the effectiveness of energy conservation education intervention for people with end-stage kidney disease receiving haemodialysis (EVEREST) in Nepal.

Symptom Management Theory (SMT) will guide this study. A pragmatic cluster randomised controlled trial (pCRT) will be conducted in one dialysis centre in Nepal. People on HD who meet the eligibility criteria will be invited to participate. The primary outcome is fatigue severity and the secondary outcome are other renal symptoms, occupational performance and health-related quality of life. Intention to treat analysis will occur and will include a change in the primary and secondary outcome. The study will provide evidence about the feasibility and effectiveness of EVEREST for symptom management.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Fatigue; End Stage Kidney Disease
• Intervention / Treatment: Other: Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysis

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Participation Criteria

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:

Participants diagnosed with ESKD and undergoing haemodialysis for ≥ 3 months, aged 18 years and above, able to speak and understand Nepali language and willing to participate will be included in this study.

Exclusion Criteria:

Participants who are in the early stage of CKD or not dependent on HD, those acutely ill, diagnosed with cognitive impairment and those who are not willing to participate will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participant of the cluster randomised to the intervention group will receive both the usual care from their healthcare providers and EVEREST delivered by the researcher who is a nurse.	Other: Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysis; The total program consisting of three educational sessions (at Week -1, week -3 and week -5) and one booster session (week -10) over a period of 12 weeks. Participants will receive individual, face to face education during their regular HD session. Education will be provided over 30-45 minutes for the first session, 30 minutes in the next two sessions and 30-45 minutes for the booster session. The lead researcher, who is a nurse, will deliver the entire intervention to avoid information bias. The simple language will be used, and emphasis will be given on the objectives of each session.
No Intervention: Control; Participants of the cluster randomised to the control group will receive usual care (standard care with no formalised, structured or tailored interventional to reduce symptom/s) from their healthcare providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Fatigue Symptom Inventory (FSI)	Fatigue Symptom Inventory (FSI) will be used to assess the severity, frequency, interference associated with fatigue and daily pattern of fatigue. The scale consists of 14 items rated on the 11-point items.	Baseline and week 4
Changes in Fatigue Symptom Inventory (FSI)	The scale consists of 14 items rated on the 11-point items.	Baseline and week 8
Changes in Fatigue Symptom Inventory (FSI)	The scale consists of 14 items rated on the 11-point items.	Baseline and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other renal symptoms	Other renal symptoms will be measured using the renal version of the IPOS (IPOS-Renal). It is a short 11-item measure, combining the most common symptoms experienced by renal patients and additional items from IPOS on concerns beyond symptoms, such as information needs, practice issues, family anxiety during the past three days. Ten questions, including 23 subitems, covers physical and psychological symptoms, carer anxiety and practical issues with optional items for any other concern. Each item is scored using a five-point Likert scale for severity and total score reflect symptom burden.	Baseline and Week 12
Occupational Performance	The Canadian Occupational Performance Measure (COPM) is a valid and reliable instrument that measures the occupational performance. The COPM is designed to identify changes in the individual's personal perceptions of occupational performance over a period of time. Individual rates their performance within the area of self-care, productivity and leisure and satisfaction with their performance. Both scales range from 1-10, with higher values indicating better performance and greater satisfaction.	Baseline and week 12
Health-related quality of life (HRQoL)	Health-related quality of life will be measured using the SF-36 which is the 36-items self-administered survey of a patient's health. There are two distinct concepts measured by the SF-36 represented by the physical component summary (PCS) and mental component summary (MCS). For each sub-scale, items are scored using a Likert scale, summed and transformed on to a scale from 0 (worst health) to 100 (best health)	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Queensland University of Technology

Publications and helpful links

General Publications

• Sharma S, Alexander KE, Green T, Wu MW, Bonner A. Energy conservation education intervention for people with end-stage kidney disease receiving haemodialysis (EVEREST): protocol for a cluster randomised control trial. BMJ Open. 2022 Feb 21;12(2):e056544. doi: 10.1136/bmjopen-2021-056544.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: End-stage kidney disease, fatigue, haemodialysis, quality of life
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Fatigue; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: SSharma

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