- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07685626
Health Coaching for Self-Management in Maintenance Hemodialysis Patients
29. juni 2026 opdateret af: 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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Anhui
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Hefei, Anhui, Kina, 230601
- The Second Affiliated Hospital of Anhui Medical University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-Management Ability
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Disease Knowledge
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2026
Primær færdiggørelse (Anslået)
31. august 2026
Studieafslutning (Anslået)
31. august 2026
Datoer for studieregistrering
Først indsendt
29. juni 2026
Først indsendt, der opfyldte QC-kriterier
29. juni 2026
Først opslået (Faktiske)
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Patologiske processer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kronisk sygdom
- Sygdomsegenskaber
- Nyreinsufficiens
- Nyreinsufficiens, kronisk
- Patologiske tilstande, tegn og symptomer
- Nyresvigt, kronisk
Andre undersøgelses-id-numre
- AHMU-HC-MHD-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
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.
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