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- Ensayo clínico NCT04342845
Effectiveness of Motivational Interviewing on Improving Care for Patients With Type 2 Diabetes in China
Effectiveness of Motivational Interviewing on Improving Care for Patients With Type 2 Diabetes in China: A Randomized Controlled Trial
n 2015, the International Diabetes Federation estimated that there were nearly 110 million diabetes mellitus (DM) patients in China, which was the highest number recorded in the world. China's DM-related costs, ranked second highest globally, were estimated to be US$51 billion. In response to the rising patient numbers and costs, the Chinese government has invested heavily in primary healthcare since 2009, with the goal of improving chronic disease management in the primary care settings. A key part of the primary care improvement program prioritizes health education as a route to lifestyle modification. Although the content and modes of delivery vary enormously, most of the programs focused on providing information rather than facilitating patient change. The impacts of traditional patient education on lifestyle modification and changes in psychological status have been reported to be suboptimal. These may be related to the poor understanding of the educational content or lack of means for making changes as a result of low socioeconomic status and poor educational level. It is therefore necessary to rethink and explore a more structured, patient-centered approach to health education at improving the outcomes of DM control.
Motivational interviewing (MI) is a collaborative, patient-centered counseling approach that aims to elicit behavior change. Counselors use empathy and other techniques to create an atmosphere to help patients to explore the discrepancies between the goals and their current behavior. The focus of MI is to find and resolve the ambivalence, improve patients' perception of the importance of behavior change, and support them to make the change. MI provides a structural framework with guiding principles that can be easily followed by the primary care doctors. Some studies show that MI can contribute to improve healthy eating, weight control and increases in physical activity, but most research focused on intermediate outcome measures and did not evaluate the readiness to change. MI can be utilized by a variety of healthcare providers, which makes it adaptable for different culture and clinical settings. However, the effectiveness of MI in Chinese diabetic patients remains uncertain.
MI has been delivered using different methods. These methods have varied and included a single one-to-one session with a therapist, multiple group sessions, and the incorporation of MI into daily clinical practice. Furthermore, in yet another study, MI education program produced a significantly greater change in patients' perceived competence in dealing with diabetes than the control group. In this study, the investigators adopted the group MI approach and developed a patient empowerment program (PEP) utilizing the techniques and framework of MI. The investigators compared this to the most common form of DM education in China, i.e., when health professionals (nurses, doctors, dietitians or pharmacists) give a lecture on DM to patients and their carers in a hospital lecture theatre in a didactic manner.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: To assess the effects of a motivational interviewing (MI)-based patient empowerment program (PEP) on type 2 diabetes mellitus (DM) patient self-management compared to traditional diabetes health education.
Methods: Two hundred and twenty-five patients, recruited from community health centers (CHCs) and the family medicine clinic in the University of Hong Kong-Shenzhen Hospital in Shenzhen, were randomly assigned to the intervention or control groups. Patients in the intervention group (n=117) received a four-session PEP in small groups over one month by trained nurses and doctors. The control group (n=108) received the traditional lecture-style health education on DM. All the patients were followed up for three months. Outcomes included problem areas in diabetes (PAID) that measures diabetes-related emotional distress, patient enablement index (PEI), mental health, patient satisfaction respectively as well as lifestyle behaviors were assessed at baseline, post-activity and three months.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Type 2 diabetes with HbA1c between 7-10%, 18-75 years old
Exclusion Criteria:
- Known severe comorbidities or complications, such as cancer, unstable angina, frequent exacerbation of chronic obstructive pulmonary disease, or diabetic retinopathy, Illiterate or not cognitively competent enough to understand written and the oral expression of the language native to the study site.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Motivational interviewing
The intervention group received an education program in small groups that included no more than ten members.
The content was designed based on MI theory and the theory of patient empowerment.
Program content was further informed by the Hospital Authority Patient Empowerment Program in Hong Kong.
The education program consisted of four modules, held once a week, that each lasted approximately 1½ to 2 hours.
They were grouped under the following four broad headings: Knowing Diabetes, Diabetes Self-Care, Healthy Diet and Physical Exercise.
Each module started with a brief introduction to relevant background knowledge, which was followed by small-group discussions about personal barriers and techniques for overcoming challenges.
During the small group discussions, educators acted as MI facilitators, using group MI techniques to strengthen participants' motivation.
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Patients in the intervention group (n=117) received a four-session patient empowerment program in small groups over one month by trained nurses and doctors. he control group received traditional lectures that consisted solely of conveying healthcare information to patients.
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Comparador de placebos: Traditional lectures
The control group received traditional lectures that consisted solely of conveying healthcare information to patients.
In order to minimize intervention bias, the control group lectures were standardized and adapted into four modules, namely knowing diabetes, healthy diet, physical exercises, and how to use medication correctly, which were similar topic headings, durations and frequencies to those of the intervention group.
Each lecture was 1 hour and was provided by one of four health professionals (a pharmacist, dietician, endocrinologist or nurse) who had never received any prior training in MI.
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Patients in the intervention group (n=117) received a four-session patient empowerment program in small groups over one month by trained nurses and doctors. he control group received traditional lectures that consisted solely of conveying healthcare information to patients.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Problem Areas in Diabetes Questionnaire
Periodo de tiempo: 4 months
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PAID is a self-administered 20-item scale.
Each item is scored from 0 (not a problem) to 4 (serious problem).
The PAID scale has been widely used in many countries to assess diabetes-related emotional distress.
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4 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
"Patient Enablement Index" (PEI) score
Periodo de tiempo: 4 months
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The PEI is a scale that measures patients' enablement, it was also used to measure patient enablement in this study.
The PEI scale had been validated in the Chinese population.
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4 months
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Stages of Change score
Periodo de tiempo: 4 months
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The Stages of Change score is a score that assess participants' readiness to change in behaviors such as smoking, drinking or exercise and their adherence to treatment.
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4 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jingya Yan, WHO Health Promoting Hospital Office, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.
- Investigador principal: Wei Liang, Endocrinology Department, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- JCYJ20150331142757385
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
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