Evaluation of the Efficiency of Proactive Telemedicine vs Face-to-Face Visits for Universal Access and Health Prevention in a Rural Primary Care Team: Randomized Non-Inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Access to Primary Healthcare
研究概览
简要总结
The study evaluates whether Proactive Telemedicine (PTM) can improve healthcare access for individuals who have not contacted their primary care team for at least one year, compared with face-to-face visits. PTM consists of brief, remote behavioral interventions addressing modifiable risk factors such as tobacco use, alcohol consumption (AUDIT-C: Alcohol Use Disorders Identification Test - Consumption), physical activity (IPAQ: International Physical Activity Questionnaire), and Mediterranean diet adherence (PREDIMED: Prevención con Dieta Mediterránea). PTM follows national preventive protocols including PAPPS (Programa de Actividades Preventivas y de Promoción de la Salud) and uses validated tools such as EuroQol-5D-5L (EQ-5D-5L) to measure healthcare accessibility and quality-of-life outcomes. This randomized non-inferiority trial aims to determine whether PTM is as effective and safe as traditional in-person consultations.
详细描述
Healthcare systems, particularly in rural and aging populations, face persistent challenges in ensuring equitable and universal access. Many individuals do not regularly engage with primary care services due to geographical, socioeconomic, organizational, or personal barriers. Digital health initiatives, including the World Health Organization's Global Strategy on Digital Health 2020-2025, highlight telemedicine as a key tool to improve accessibility and support preventive care.
Proactive Telemedicine (PTM) is a model in which primary care professionals initiate remote contact with individuals who have not interacted with their healthcare team for at least one year. The intervention uses synchronous (telephone) and asynchronous (secure messaging) communication to deliver brief behavioral counseling based on cognitive-behavioral and motivational interviewing principles. These interventions target modifiable lifestyle factors such as smoking, alcohol consumption, physical inactivity, and dietary patterns, and are aligned with national preventive care recommendations.
This randomized non-inferiority trial evaluates whether PTM provides accessibility, preventive impact, and user experience comparable to face-to-face consultations. The study examines whether proactively delivered telemedicine can serve as a scalable and acceptable strategy to increase engagement with primary care services in underserved rural areas. The information obtained will help determine the feasibility, effectiveness, and future implementation potential of PTM within broader healthcare systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Registered patients of EAP Anoia Rural
- •Age ≥18 years
- •No contact with the primary care team within the previous 12 months
- •Able to provide informed consent (electronic or paper)
排除标准
- •Proxy care (consulted by caregivers without patient present).
- •Inability to communicate.
- •Severe cognitive or psychiatric impairment.
- •Advanced or palliative chronic conditions (MACA: Modelo de Atención Crónica Avanzada - Advanced Chronic Care Model).
- •Outdated contact information.
结局指标
主要结局
Access to Primary Healthcare
时间窗: 12-month post-intervention
Proportion of participants who initiate any contact with primary care during the 12-month post-intervention observation period. Unit of Measure: Proportion (%)
Health-Related Quality of Life, EuroQol-5D-5L (EQ-5D-5L)
时间窗: Baseline, 4 months, 8 months
Change in quality-of-life score measured using the EuroQol-5D-5L instrument. Unit of Measure: Index score (0-1)
次要结局
- Smoking Status(Baseline, 4 months, 8 months)
- Morbidity Assessment(Baseline to 8 months)
- Alcohol Consumption (AUDIT-C)(Baseline, 4 months, 8 months)
- Mediterranean Diet Adherence (PREDIMED)(Baseline, 4 months, 8 months)
- Physical Activity (IPAQ)(Baseline, 4 months, 8 months)
- Stage of Behavioral Change(Baseline, 4 months, 8 months)
- Coronary Risk (REGICOR Score)(Baseline and 8 months)
- Patient Satisfaction(At 8 months)
- Adverse Effects(Baseline to 8 months)
研究者
Robert Panades Zafra
MD, Primary Care Physician, EAP Anoia Rural, Catalonia, Spain
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina