FatigueNCT04360408
The Energy Conservation Education Intervention
A study testing Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysis in people with Fatigue and End Stage Kidney Disease, run by Queensland University of Technology.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, End Stage Kidney Disease, Quality of Life
- What is being tested?
- Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Fatigue, End Stage Kidney Disease, Quality of Life
- Being tested
- Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysis
- Keywords
- End-stage kidney disease, fatigue, haemodialysis, quality of life
- Medical subject headings
- Fatigue, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 4
Changes in Fatigue Symptom Inventory (FSI)
The scale consists of 14 items rated on the 11-point items.
Measured: Baseline and week 8
Changes in Fatigue Symptom Inventory (FSI)
The scale consists of 14 items rated on the 11-point items.
Measured: Baseline and week 12
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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)
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study startAug 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queensland University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sita Sharma, Queensland University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360408
- Sponsor's protocol ID
- SSharma
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40101671Sharma 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.
PubMed 35190440
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Energy Conservation Education Intervention For People With End-stage Kidney Disease Receiving Haemodialysis (EVEREST)
- ClinicalTrials.gov ID
- NCT04360408
- Acronym / sponsor ID
- SSharma
- Conditions
- Fatigue, End Stage Kidney Disease, Quality of Life
- Keywords
- End-stage kidney disease, fatigue, haemodialysis, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Queensland University of TechnologyUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysisParticipant 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysisThe 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. | Other | Intervention |
Primary outcome
Changes in Fatigue Symptom Inventory (FSI)
Time frame: Baseline and week 4
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)
Time frame: Baseline and week 8
The scale consists of 14 items rated on the 11-point items.
Changes in Fatigue Symptom Inventory (FSI)
Time frame: Baseline and week 12
The scale consists of 14 items rated on the 11-point items.
3 secondary outcomes
Other renal symptoms
Time frame: Baseline and Week 12
Occupational Performance
Time frame: Baseline and week 12
Health-related quality of life (HRQoL)
Time frame: Baseline and Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 40101671Sharma 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.
- Derived from this study: PubMed 35190440Sharma 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysis in people with Fatigue and End Stage Kidney Disease, run by Queensland University of Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fatigue Symptom Inventory (FSI) (time frame: Baseline and week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360408, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.