The Energy Conservation Education Intervention

NCT ID: NCT04360408

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Fatigue End Stage Kidney Disease Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queensland University of Technology

OTHER

Sponsor Role lead

Responsible Party

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Sita Sharma

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 40101671 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35190440 (View on PubMed)

Other Identifiers

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SSharma

Identifier Type: -

Identifier Source: org_study_id

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