Health Coaching for Self-Management in Maintenance Hemodialysis Patients
2026年6月29日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Anhui
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Hefei、Anhui、中国、230601
- The Second Affiliated Hospital of Anhui Medical University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Self-Management Ability
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Disease Knowledge
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年3月1日
一次修了 (推定)
2026年8月31日
研究の完了 (推定)
2026年8月31日
試験登録日
最初に提出
2026年6月29日
QC基準を満たした最初の提出物
2026年6月29日
最初の投稿 (実際)
2026年7月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月6日
QC基準を満たした最後の更新が送信されました
2026年6月29日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- AHMU-HC-MHD-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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