The Energy Conservation Education Intervention

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04360408
• Other study ID #: SSharma
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: February 2023

Study information

• Verified date: April 2020
• Source: Queensland University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: February 2023
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Fatigue
• Kidney Diseases
• Kidney Failure, Chronic
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Queensland University of Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes in Fatigue Symptom Inventory (FSI)	The scale consists of 14 items rated on the 11-point items.	Baseline and week 8
Primary	Changes in Fatigue Symptom Inventory (FSI)	The scale consists of 14 items rated on the 11-point items.	Baseline and week 12
Secondary	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
Secondary	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
Secondary	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