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NCT Number: NCT07685626

Health Coaching for Self-Management in Maintenance Hemodialysis Patients

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.

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Key information

Conditions

End-Stage Kidney Disease (ESKD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Maintenance Hemodialysis (MHD) Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health Coaching

Behavioral

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

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Official study title

Effects of Health Coaching on Self-Management Ability in Patients Undergoing Maintenance Hemodialysis: A Quasi-Experimental Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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