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The Energy Conservation Education Intervention

Primary Purpose

Fatigue, End Stage Kidney Disease, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysis
Sponsored by
Queensland University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring End-stage kidney disease, fatigue, haemodialysis, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

    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.
    Changes in Fatigue Symptom Inventory (FSI)
    The scale consists of 14 items rated on the 11-point items.
    Changes in Fatigue Symptom Inventory (FSI)
    The scale consists of 14 items rated on the 11-point items.

    Secondary Outcome Measures

    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.
    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.
    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)

    Full Information

    First Posted
    April 21, 2020
    Last Updated
    April 23, 2020
    Sponsor
    Queensland University of Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04360408
    Brief Title
    The Energy Conservation Education Intervention
    Official Title
    The Energy Conservation Education Intervention For People With End-stage Kidney Disease Receiving Haemodialysis (EVEREST)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2020 (Anticipated)
    Primary Completion Date
    June 2021 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Queensland University of Technology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatigue, End Stage Kidney Disease, Quality of Life
    Keywords
    End-stage kidney disease, fatigue, haemodialysis, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    126 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysis
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in Fatigue Symptom Inventory (FSI)
    Description
    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.
    Time Frame
    Baseline and week 4
    Title
    Changes in Fatigue Symptom Inventory (FSI)
    Description
    The scale consists of 14 items rated on the 11-point items.
    Time Frame
    Baseline and week 8
    Title
    Changes in Fatigue Symptom Inventory (FSI)
    Description
    The scale consists of 14 items rated on the 11-point items.
    Time Frame
    Baseline and week 12
    Secondary Outcome Measure Information:
    Title
    Other renal symptoms
    Description
    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.
    Time Frame
    Baseline and Week 12
    Title
    Occupational Performance
    Description
    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.
    Time Frame
    Baseline and week 12
    Title
    Health-related quality of life (HRQoL)
    Description
    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)
    Time Frame
    Baseline and Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35190440
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    The Energy Conservation Education Intervention

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