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Health Coaching for Self-Management in Maintenance Hemodialysis Patients

29 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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.
Outro: 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.
Comparador Ativo: 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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Self-Management Ability
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Disease Knowledge
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Anhui Medical University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de março de 2026

Conclusão Primária (Estimado)

31 de agosto de 2026

Conclusão do estudo (Estimado)

31 de agosto de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

29 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de junho de 2026

Primeira postagem (Real)

6 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • AHMU-HC-MHD-2026

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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