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| Name | Class |
|---|---|
| Institut Catala de Salut | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Proactive Telemedicine (PTM) | Active Comparator | Participants receive proactive remote contact by telephone or secure electronic messaging. A standardized brief behavioral intervention is delivered at baseline, four months, and eight months, focusing on smoking status, alcohol consumption, Mediterranean diet adherence, and physical activity. The stage of behavioral change is assessed to tailor motivational strategies. Participants then enter an observational phase to monitor natural healthcare utilization. |
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| Arm 2: Face-to-Face Consultation | Active Comparator | Participants attend in-person appointments at the health center at baseline, four months, and eight months. Each visit includes the same standardized behavioral intervention used in the PTM arm. Participants then enter an observational phase. Intervention: Face-to-Face Brief Behavioral Lifestyle Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine Brief Behavioural Lifestyle Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Access to Primary Healthcare | Proportion of participants who initiate any contact with primary care during the 12-month post-intervention observation period. Unit of Measure: Proportion (%) | 12-month post-intervention |
| Health-Related Quality of Life, EuroQol-5D-5L (EQ-5D-5L) | Change in quality-of-life score measured using the EuroQol-5D-5L instrument. Unit of Measure: Index score (0-1) | Baseline, 4 months, 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Status | Change in categorical smoking status (smoker/non-smoker). Unit of Measure: Categorical. | Baseline, 4 months, 8 months |
| Alcohol Consumption (AUDIT-C) | Change in score on the AUDIT-C questionnaire. Unit of Measure: Score (0-12). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josep Vidal Alaball, PhD | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | Study Director |
| Robert Panadés Zafra, MD | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EAP Anoia rural. Gerència d'Atenció Primària i a la comunitària Penedès. Institut Català de la Salut. Departament de Salut. Generalitat de Catalunya | Igualada | Barcelona | 08700 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39190446 | Background | Osman S, Churruca K, Ellis LA, Luo D, Braithwaite J. The Unintended Consequences of Telehealth in Australia: Critical Interpretive Synthesis. J Med Internet Res. 2024 Aug 27;26:e57848. doi: 10.2196/57848. | |
| 32813281 | Background | Goncalves-Bradley DC, J Maria AR, Ricci-Cabello I, Villanueva G, Fonhus MS, Glenton C, Lewin S, Henschke N, Buckley BS, Mehl GL, Tamrat T, Shepperd S. Mobile technologies to support healthcare provider to healthcare provider communication and management of care. Cochrane Database Syst Rev. 2020 Aug 18;8(8):CD012927. doi: 10.1002/14651858.CD012927.pub2. |
| Label | URL |
|---|---|
| Background resource on access to health services as a social determinant of health, from Healthy People 2030. | View source |
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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.
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|
| Face to face Brief Behavioural Lifestyle Intervention | Behavioral | 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. |
|
| Baseline, 4 months, 8 months |
| Mediterranean Diet Adherence (PREDIMED) | Change in PREDIMED score. Unit of Measure: Score (0-14). | Baseline, 4 months, 8 months |
| Physical Activity (IPAQ) | Change in physical activity level. Unit of Measure: MET-minutes/week (Low: <600, Moderate: 600-2999, High: ≥3000) | Baseline, 4 months, 8 months |
| Stage of Behavioral Change | Change in stage of change using transtheoretical model. Unit of Measure: Categorical (precontemplation, contemplation, preparation, action, maintenance, relapse) | Baseline, 4 months, 8 months |
| Coronary Risk (REGICOR Score) | Change in 10-year coronary risk percentage calculated using REGICOR function. Unit of Measure: Percentage (%), | Baseline and 8 months |
| Morbidity Assessment | Change in number and type of chronic conditions documented in electronic health records (ECAP). Unit of Measure: Count of conditions. | Baseline to 8 months |
| Patient Satisfaction | Satisfaction score using validated telemedicine satisfaction survey (adapted from Tovar-Martínez et al.). Unit of Measure: Score (Likert scale). | At 8 months |
| Adverse Effects | Number of intervention-related adverse events. Unit of Measure: Count | Baseline to 8 months |
| Background | Direcció General de Planificació en Salut. Document tècnic de l'Enquesta de salut de Catalunya 2021. Barcelona; 2022 Jun. |
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