The Energy Conservation Education Intervention

NCT04360408 | Unknown

• 1 other identifier: SSharma
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Fatigue; End Stage Kidney Disease; Quality of Life

Keywords

End-stage kidney disease, fatigue, haemodialysis, quality of life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Other renal symptoms

  Baseline and Week 12

• Occupational Performance

  Baseline and week 12

• Health-related quality of life (HRQoL)

  Baseline and Week 12

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysis OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queensland University of Technology: lead

Related Publications (2)

• Sharma S, Alexander KE, Green T, Wu ML, Bonner A. Energy conservation education intervention for people with end-stage kidney disease receiving haemodialysis (EVEREST): A two-arm parallel group study. Int J Nurs Stud. 2025 Jun;166:105032. doi: 10.1016/j.ijnurstu.2025.105032. Epub 2025 Feb 24.

  PMID: 40101671 DERIVED

• 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.

  PMID: 35190440 DERIVED

MeSH Terms

Conditions

Fatigue; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: August 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: February 1, 2023
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share