Health Coaching for Self-Management in Maintenance Hemodialysis Patients
29 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Activo, no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Anhui
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Hefei, Anhui, Porcelana, 230601
- The Second Affiliated Hospital of Anhui Medical University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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Comparador activo: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-Management Ability
Periodo de tiempo: Baseline, 3 months after the intervention, and 6 months after the intervention
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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.
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Baseline, 3 months after the intervention, and 6 months after the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Disease Knowledge
Periodo de tiempo: 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.
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Baseline, 3 months after the intervention, and 6 months after the intervention
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Self-Efficacy
Periodo de tiempo: Baseline, 3 months after the intervention, and 6 months after the intervention
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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.
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Baseline, 3 months after the intervention, and 6 months after the intervention
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Treatment Adherence
Periodo de tiempo: Baseline, 3 months after the intervention, and 6 months after the intervention
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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.
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Baseline, 3 months after the intervention, and 6 months after the intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de marzo de 2026
Finalización primaria (Estimado)
31 de agosto de 2026
Finalización del estudio (Estimado)
31 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
29 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de junio de 2026
Publicado por primera vez (Actual)
6 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Insuficiencia renal
- Insuficiencia Renal Crónica
- Condiciones Patológicas, Signos y Síntomas
- Insuficiencia Renal Crónica
Otros números de identificación del estudio
- AHMU-HC-MHD-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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