Self-management Intervention for People With Cardiometabolic Multimorbidity: A Pilot Randomized Controlled Trial
2 de septiembre de 2026 actualizado por: Rui She, The Hong Kong Polytechnic University
A Multi-faceted Self-management Intervention for Improving Patient Activation and Lifestyle Behavior Modification Among People With Cardiometabolic Multimorbidity: A Pilot Randomized Controlled Trial
This pilot randomized controlled trial aims to evaluate the feasibility and preliminary effects of a telephone-based self-management intervention for adults with cardiometabolic multimorbidity. Cardiometabolic multimorbidity refers to having two or more chronic cardiometabolic conditions, such as hypertension, type 2 diabetes, hyperlipidemia, metabolic syndrome, coronary heart disease, or stroke.
The intervention integrates motivational interviewing, self-affirmation, and problem-solving training to support participants in improving their motivation, confidence, and skills for chronic disease self-management and lifestyle behavior modification.
Participants will be randomly assigned to either the intervention group or the usual care group. The intervention group will receive two biweekly telephone consultation sessions. The control group will receive usual care according to government guidelines. All participants will complete assessments at baseline, immediately after the intervention, and 3 months after the intervention.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
72
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Rui She, PhD
- Número de teléfono: +85227665693
- Correo electrónico: sherryshe0319@link.cuhk.edu.hk
Ubicaciones de estudio
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Hong Kong
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Hong Kong, Hong Kong, Porcelana
- The Hong Kong Polytechnic University
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Contacto:
- Rui She, PhD
- Número de teléfono: +852 2766 5693
- Correo electrónico: sherryshe0319@link.cuhk.edu.hk
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- aged ≥18 years
- having at least two chronic cardiometabolic diseases (i.e., hypertension, type 2 diabetes, hyperlipidemia, metabolic syndrome, coronary heart disease, or stroke) as confirmed by a doctor or the use of corresponding prescription medications/treatment
- having mobile phones
- mentally competent to understand the study.
Exclusion Criteria:
- current participation in similar projects or serious or life-threatening medical conditions (e.g., cancer, end-stage renal disease with dialysis, dementia) that would hinder study procedures.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: MSP-MI
The intervention will comprise two biweekly telephone consultations, conducted by well-trained RAs with expertise in social science, health psychology, or behavioral medicine.
These consultations will utilize MI blended with behavioral change techniques, including self-affirmation and problem-solving training.
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The proposed study will use an MI-based intervention, blended and strengthened by self-affirmation and problem-solving techniques (MSP-SMI) to improve patient activation and lifestyle modification in patients with multimorbidity in HK.
This integrated intervention is designed to tackle key behavioral change processes as posited in the IMB model and thus may have enhanced efficacy.
Otros nombres:
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Comparador de placebos: Usual care
The control group will receive usual care accordingly to government guidelines.
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The control group will receive usual care accordingly to government guidelines.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Retention rate at 3 months
Periodo de tiempo: From randomization to the end of intervention at 3 months
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Proportion of randomized participants who complete the 3-month primary assessment
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From randomization to the end of intervention at 3 months
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Intervention adherence rate
Periodo de tiempo: From enrollment to the end of intervention
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Proportion of participants who attend all the scheduled intervention sessions
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From enrollment to the end of intervention
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Recruitment rate
Periodo de tiempo: From the start of recruitment to completion of enrollment
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Proportion of eligible individuals who consent and are randomized.
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From the start of recruitment to completion of enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in mental health from baseline to 3 months
Periodo de tiempo: From baseline to the end of intervention at 3 months
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Mental health will be assessed using the Patient Health Questionnaire-4, with higher scores indicating greater mental distress.
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From baseline to the end of intervention at 3 months
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Change in patient activation from baseline to 3 months
Periodo de tiempo: From baseline to the end of intervention at 3 months
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Patient activation will be assessed using the 13-item Patient Activation Measure.
The PAM-13 consists of 13 items on a 4-point Likert scale.
Item scores are summed up to a raw sum score resulting in theoretical values between 13 and 52, which are then transformed to a standardized metric ranging from 0 to 100.
Higher scores indicate greater patient activation.
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From baseline to the end of intervention at 3 months
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Change in health behavior from baseline to 3 months
Periodo de tiempo: From baseline to the end of intervention at 3 months
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Health behavior will be assessed using the 12-item Simple Lifestyle Indicator Questionnaire.
The SLIQ has 5 components: diet (3 questions), activity (3 questions), alcohol consumption (3 questions), smoking (2 questions), and stress (1 question).
For each component, a raw score and a category score can be calculated.
To provide equal weighting for each component, the overall SLIQ score is based on the 5 category scores.
Each component has a category score of 0, 1, or 2, so overall SLIQ scores can range from 0 to 10.
The higher the score, the healthier the lifestyle.
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From baseline to the end of intervention at 3 months
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Change in motivation for behavior change from baseline to 3 months
Periodo de tiempo: From baseline to the end of intervention at 3 months
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Motivation for behavior change will be assessed using the Contemplation Ladder.
It displays a picture of a ladder numbered from 0 to 10. Higher scores indicate greater readiness or motivation to change health behavior.
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From baseline to the end of intervention at 3 months
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Change in self-efficacy for managing chronic disease from baseline to 3 months
Periodo de tiempo: From baseline to the end of intervention at 3 months
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Self-efficacy for managing chronic disease will be assessed using the six-item Self-Efficacy for Managing Chronic Disease Scale.
It has a 10-point Likert-type scoring system (1 = Not at all confident, 10 = Totally confident).
The total scores range from 6 to 60, with higher scores indicating greater self-efficacy.
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From baseline to the end of intervention at 3 months
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Change in health-related quality of life from baseline to 3 months
Periodo de tiempo: From baseline to the end of intervention at 3 months
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Health-related quality of life will be assessed using the 5 levels of severity for each of the 5 dimensions from the EuroQoL Group (EQ-5D-5L), which consists of 2 parts: the EQ-5D and EQ visual analog scale.
The EQ-5D-5L utility index score will be calculated using the value set of the appropriate population (typically range from less than 0 up to 1 for full health), with higher scores indicating better health-related quality of life.
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From baseline to the end of intervention at 3 months
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Change in self-rated health status from baseline to 3 months
Periodo de tiempo: From baseline to the end of intervention at 3 months
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Self-rated health status will be assessed using the EQ visual analog scale of 5 levels of severity for each of the 5 dimensions from the EuroQoL Group (EQ-5D-3L).
Scores range from 0 to 100, with higher scores indicating better self-rated health.
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From baseline to the end of intervention at 3 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Qualitative process evaluation of intervention feasibility and acceptability
Periodo de tiempo: From enrollment to the end of intervention at 3 months
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Approximately 20-30 participants will be invited to participate in semi-structured interviews, or until thematic saturation is reached.
Interviews will explore participants' experiences, perceived feasibility, acceptability, barriers, and facilitators related to the intervention.
Qualitative data will be audio-recorded, transcribed, and analyzed thematically.
Findings will be reported narratively and will not be aggregated into a single quantitative score.
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From enrollment to the end of intervention at 3 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: rui she, PhD, The Hong Kong Polytechnic University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
31 de agosto de 2026
Finalización primaria (Estimado)
31 de octubre de 2027
Finalización del estudio (Estimado)
31 de octubre de 2027
Fechas de registro del estudio
Enviado por primera vez
10 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de agosto de 2026
Publicado por primera vez (Actual)
28 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Comportamiento
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Aceptación del paciente de la atención médica
- Participación del paciente
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Disciplinas y actividades de comportamiento
- Asesoramiento directivo
- Asesoramiento
- Servicios de salud mental
- Entrevistas motivacionales
Otros números de identificación del estudio
- Ref. 22231741
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
he data sharing plan has not yet been finalized and will be determined in accordance with participant consent, institutional policies, and ethics approval requirements.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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