- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07685626
Health Coaching for Self-Management in Maintenance Hemodialysis Patients
June 29, 2026 updated by: Sirong Zhao, Anhui Medical University
Effects of Health Coaching on Self-Management Ability in Patients Undergoing Maintenance Hemodialysis: A Quasi-Experimental Study
This study is a quasi-experimental study designed to evaluate the effects of a health coaching intervention on self-management ability in patients undergoing maintenance hemodialysis.
Patients receiving maintenance hemodialysis will be recruited from the hemodialysis center of the study hospital.
Participants in the intervention group will receive a structured health coaching intervention in addition to routine care, while participants in the control group will receive routine care.
The intervention aims to improve patients' self-management ability by providing individualized health education, goal setting, self-management guidance, follow-up support, and feedback.
The main outcome of this study is self-management ability.
Secondary outcomes may include self-efficacy, disease knowledge, and treatment adherence.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Anhui
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Hefei, Anhui, China, 230601
- The Second Affiliated Hospital of Anhui Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients aged ≥18 years who met the diagnostic criteria for ESRD according to the KDIGO 2012 Clinical Practice Guideline, namely a glomerular filtration rate of less than 15 mL/min/1.73 m².
- Patients who have received regular maintenance hemodialysis for at least 3 months, with a dialysis frequency of three times per week.
- Patients with a relatively stable clinical condition and no severe complications that may affect participation in the study.
- Patients who are conscious, have normal communication ability, and are able to cooperate in completing the study procedures and questionnaires.
- Patients who have no plan to change dialysis centers or travel for an extended period during the intervention period.
- Patients who voluntarily agree to participate in this study and provide informed consent.
Exclusion Criteria:
- Patients with severe cognitive impairment, mental disorder, or communication difficulties that prevent participation in the intervention or completion of questionnaires.
- Patients with severe acute illness or unstable clinical condition.
- Patients who are unable or unwilling to complete the 6-month intervention or follow-up.
- Patients participating in another similar intervention study during the same period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health Coaching Group
Participants in this group will receive routine treatment and nursing care plus a structured 6-month health coaching intervention.
The intervention will be delivered through face-to-face communication during dialysis and follow-up support via a WeChat group.
It will follow eight steps: contact, observation, education, reinforcement, clarification, assistance, encouragement, and guidance.
The main components include individualized assessment and establishment of electronic health records, hemodialysis-related health education, knowledge reinforcement using the teach-back method, individualized goal setting and action planning, health diary recording, family support, feedback on goal achievement, behavioral encouragement, emotional support, and long-term self-management guidance throughout the 6-month intervention period.
|
The health coaching intervention is a structured 6-month behavioral intervention delivered in addition to routine treatment and nursing care.
It includes face-to-face communication during dialysis and follow-up support via a WeChat group.
The intervention follows eight steps: contact, observation, education, reinforcement, clarification, assistance, encouragement, and guidance.
Main components include individualized assessment, hemodialysis-related health education, teach-back-based knowledge reinforcement, individualized goal setting, action planning, health diary recording, family support, feedback on goal achievement, behavioral encouragement, emotional support, and long-term self-management guidance.
Routine care includes regular maintenance hemodialysis, routine treatment and nursing care, basic health education, dietary and fluid management guidance, vascular access care guidance, medication guidance, and answers to patients' health-related questions as needed during the 6-month study period.
|
|
Active Comparator: Routine Care Group
Participants in this group will receive routine treatment and nursing care provided by the hemodialysis center during the 6-month study period.
Routine care includes regular maintenance hemodialysis, routine nursing assessment, basic health education, dietary and fluid management guidance, vascular access care guidance, medication guidance, and answers to patients' health-related questions as needed.
Participants in this group will not receive the structured health coaching intervention.
|
Routine care includes regular maintenance hemodialysis, routine treatment and nursing care, basic health education, dietary and fluid management guidance, vascular access care guidance, medication guidance, and answers to patients' health-related questions as needed during the 6-month study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Management Ability
Time Frame: Baseline, 3 months after the intervention, and 6 months after the intervention
|
Self-management ability will be assessed using the Maintenance Hemodialysis Self-Management Scale at baseline, 3 months after the intervention, and 6 months after the intervention.
The scale consists of 20 items and includes four dimensions: problem solving, self-care, partnership, and emotional management.
Each item is scored on a 4-point Likert scale, ranging from 1 to 4. The total score ranges from 20 to 80, with higher scores indicating better self-management behavior.
Changes in self-management ability across the three time points will be evaluated.
|
Baseline, 3 months after the intervention, and 6 months after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease Knowledge
Time Frame: Baseline, 3 months after the intervention, and 6 months after the intervention
|
Disease knowledge will be assessed using the Maintenance Hemodialysis Patient Knowledge Questionnaire at baseline, 3 months after the intervention, and 6 months after the intervention.
The questionnaire consists of 24 items covering five topics: anemia, diet and medication, kidney function, dialysis treatment, and rehabilitation.
Each item is scored as 1 for a correct answer and 0 for an incorrect or "do not know" answer.
The total score ranges from 0 to 24, with higher scores indicating a higher level of disease knowledge.
Changes in disease knowledge across the three time points will be evaluated.
|
Baseline, 3 months after the intervention, and 6 months after the intervention
|
|
Self-Efficacy
Time Frame: Baseline, 3 months after the intervention, and 6 months after the intervention
|
Self-efficacy will be assessed using the Chronic Disease Self-Efficacy Scale at baseline, 3 months after the intervention, and 6 months after the intervention.
The scale consists of 6 items and includes two dimensions: symptom management and common disease management.
Each item is scored from 1 to 10, ranging from "not at all confident" to "totally confident."
The total score is calculated as the mean score of the 6 items, ranging from 1 to 10. Higher scores indicate higher levels of self-efficacy.
Changes in self-efficacy across the three time points will be evaluated.
|
Baseline, 3 months after the intervention, and 6 months after the intervention
|
|
Treatment Adherence
Time Frame: Baseline, 3 months after the intervention, and 6 months after the intervention
|
Treatment adherence will be assessed using the Maintenance Hemodialysis Patient Treatment Adherence Scale at baseline, 3 months after the intervention, and 6 months after the intervention.
The scale consists of 23 items and includes four dimensions: dietary adherence, fluid adherence, medication adherence, and dialysis adherence.
Each item is scored on a 5-point scale, with higher scores indicating better treatment adherence.
Changes in treatment adherence across the three time points will be evaluated.
|
Baseline, 3 months after the intervention, and 6 months after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2026
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
June 29, 2026
First Submitted That Met QC Criteria
June 29, 2026
First Posted (Actual)
July 6, 2026
Study Record Updates
Last Update Posted (Actual)
July 6, 2026
Last Update Submitted That Met QC Criteria
June 29, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Pathological Conditions, Signs and Symptoms
- Kidney Failure, Chronic
Other Study ID Numbers
- AHMU-HC-MHD-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be publicly shared due to privacy protection and ethical restrictions.
The study involves patients undergoing maintenance hemodialysis, and the collected data include questionnaire responses and clinical information.
To protect participant confidentiality, only aggregated and de-identified results will be reported in publications or presentations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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