Adverse Effects, Behavior Change Interventions, Brief Intervention, Cardiovascular (CV) Risk, Face to Face Consultation, Health Care Access, Prevention, Primary Health Care, Quality of Life, Telemedicine
Conditions
Keywords
telemedicine, primary care access, non-inferiority trial, health behavior change, rural healthcare, preventive medicine, quality of life, proactive intervention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTelemedicine Brief Behavioural Lifestyle Intervention
Participants received proactive digital contact via phone or e-consultation. They underwent a brief behavioural intervention addressing modifiable lifestyle factors such as smoking, alcohol consumption, physical activity, and diet. Additionally, access to the rural primary healthcare system will also be measured.
BEHAVIORALFace to face Brief Behavioural Lifestyle Intervention
Participants attend in-person visits where they undergo a brief behavioural intervention addressing modifiable lifestyle factors (smoking, alcohol, physical activity, diet). Additionally, access to the rural primary healthcare system is also measured.
Sponsors
Institut Catala de Salut
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
The study uses a two-arm parallel assignment model in which participants are randomly allocated to either the proactive telemedicine intervention or standard face-to-face care. Each participant remains in their assigned arm for the duration of the study, with no crossover.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Access to Primary Healthcare | 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mediterranean Diet Adherence (PREDIMED) | Baseline, 4 months, 8 months | Change in PREDIMED score. Unit of Measure: Score (0-14). |
| Physical Activity (IPAQ) | Baseline, 4 months, 8 months | Change in physical activity level. Unit of Measure: MET-minutes/week (Low: \<600, Moderate: 600-2999, High: ≥3000) |
| Stage of Behavioral Change | Baseline, 4 months, 8 months | Change in stage of change using transtheoretical model. Unit of Measure: Categorical (precontemplation, contemplation, preparation, action, maintenance, relapse) |
| Smoking Status | Baseline, 4 months, 8 months | Change in categorical smoking status (smoker/non-smoker). Unit of Measure: Categorical. |
| Morbidity Assessment | Baseline to 8 months | Change in number and type of chronic conditions documented in electronic health records (ECAP). Unit of Measure: Count of conditions. |
| Patient Satisfaction | At 8 months | Satisfaction score using validated telemedicine satisfaction survey (adapted from Tovar-Martínez et al.). Unit of Measure: Score (Likert scale). |
| Adverse Effects | Baseline to 8 months | Number of intervention-related adverse events. Unit of Measure: Count |
| Coronary Risk (REGICOR Score) | Baseline and 8 months | Change in 10-year coronary risk percentage calculated using REGICOR function. Unit of Measure: Percentage (%), |
| Alcohol Consumption (AUDIT-C) | Baseline, 4 months, 8 months | Change in score on the AUDIT-C questionnaire. Unit of Measure: Score (0-12). |
Countries
Spain
Outcome results
None listed