NCT07685626

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Mar 2026Aug 2026

Study Start

First participant enrolled

March 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 29, 2026

Last Update Submit

June 29, 2026

Conditions

Keywords

Maintenance HemodialysisHealth CoachingSelf-ManagementSelf-EfficacyNursing Intervention

Outcome Measures

Primary Outcomes (1)

  • Self-Management Ability

    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

Secondary Outcomes (3)

  • Disease Knowledge

    Baseline, 3 months after the intervention, and 6 months after the intervention

  • Self-Efficacy

    Baseline, 3 months after the intervention, and 6 months after the intervention

  • Treatment Adherence

    Baseline, 3 months after the intervention, and 6 months after the intervention

Study Arms (2)

Health Coaching Group

EXPERIMENTAL

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.

Behavioral: Health CoachingOther: Routine Care

Routine Care Group

ACTIVE COMPARATOR

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.

Other: Routine Care

Interventions

Health CoachingBEHAVIORAL

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.

Health Coaching Group

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.

Health Coaching GroupRoutine Care Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be assigned to either the health coaching group or the routine care group according to the quasi-experimental study design. The health coaching group will receive a structured health coaching intervention in addition to routine care, while the routine care group will receive routine care only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

June 29, 2026

First Posted

July 6, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations