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Health Coaching for Self-Management in Maintenance Hemodialysis Patients

29 июня 2026 г. обновлено: 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.

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

60

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Китай
    • Anhui
      • Hefei, Anhui, Китай, 230601
        • The Second Affiliated Hospital of Anhui Medical University

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  1. 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.
  2. Patients who have received regular maintenance hemodialysis for at least 3 months, with a dialysis frequency of three times per week.
  3. Patients with a relatively stable clinical condition and no severe complications that may affect participation in the study.
  4. Patients who are conscious, have normal communication ability, and are able to cooperate in completing the study procedures and questionnaires.
  5. Patients who have no plan to change dialysis centers or travel for an extended period during the intervention period.
  6. Patients who voluntarily agree to participate in this study and provide informed consent.

Exclusion Criteria:

  1. Patients with severe cognitive impairment, mental disorder, or communication difficulties that prevent participation in the intervention or completion of questionnaires.
  2. Patients with severe acute illness or unstable clinical condition.
  3. Patients who are unable or unwilling to complete the 6-month intervention or follow-up.
  4. Patients participating in another similar intervention study during the same period.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Нерандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Поведенческий: Health Coaching
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.
Другой: Routine Care
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.
Активный компаратор: 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.
Другой: Routine Care
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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Self-Management Ability
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Disease Knowledge
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Anhui Medical University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 марта 2026 г.

Первичное завершение (Оцененный)

31 августа 2026 г.

Завершение исследования (Оцененный)

31 августа 2026 г.

Даты регистрации исследования

Первый отправленный

29 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

29 июня 2026 г.

Первый опубликованный (Действительный)

6 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

6 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

29 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • AHMU-HC-MHD-2026

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана 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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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