Health Coaching for Self-Management in Maintenance Hemodialysis Patients
2026년 6월 29일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Anhui
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Hefei, Anhui, 중국, 230601
- The Second Affiliated Hospital of Anhui Medical University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Self-Management Ability
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Disease Knowledge
기간: Baseline, 3 months after the intervention, and 6 months after the intervention
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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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 3월 1일
기본 완료 (추정된)
2026년 8월 31일
연구 완료 (추정된)
2026년 8월 31일
연구 등록 날짜
최초 제출
2026년 6월 29일
QC 기준을 충족하는 최초 제출
2026년 6월 29일
처음 게시됨 (실제)
2026년 7월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 29일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- AHMU-HC-MHD-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .