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Active, Not Recruiting

NCT Number: NCT07299201

Proactive Telemedicine to Improve Healthcare Access and Prevention in Rural Primary Care (PTM)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Health Care Adverse Effects Behavior Change Interventions Brief Intervention Cardiovascular (CV) Risk Face to Face Consultation Health Care Access Prevention Quality of Life Telemedicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Access to Primary Healthcare

    Time frame: 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 (%)

  2. Health-Related Quality of Life, EuroQol-5D-5L (EQ-5D-5L)

    Time frame: 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 outcomes

  1. Smoking Status

    Time frame: Baseline, 4 months, 8 months

    Change in categorical smoking status (smoker/non-smoker). Unit of Measure: Categorical.

  2. Alcohol Consumption (AUDIT-C)

    Time frame: Baseline, 4 months, 8 months

    Change in score on the AUDIT-C questionnaire. Unit of Measure: Score (0-12).

  3. Mediterranean Diet Adherence (PREDIMED)

    Time frame: Baseline, 4 months, 8 months

    Change in PREDIMED score. Unit of Measure: Score (0-14).

  4. Physical Activity (IPAQ)

    Time frame: Baseline, 4 months, 8 months

    Change in physical activity level. Unit of Measure: MET-minutes/week (Low: <600, Moderate: 600-2999, High: ≥3000)

  5. Stage of Behavioral Change

    Time frame: Baseline, 4 months, 8 months

    Change in stage of change using transtheoretical model. Unit of Measure: Categorical (precontemplation, contemplation, preparation, action, maintenance, relapse)

  6. Coronary Risk (REGICOR Score)

    Time frame: Baseline and 8 months

    Change in 10-year coronary risk percentage calculated using REGICOR function. Unit of Measure: Percentage (%),

  7. Morbidity Assessment

    Time frame: Baseline to 8 months

    Change in number and type of chronic conditions documented in electronic health records (ECAP).

    Unit of Measure: Count of conditions.

  8. Patient Satisfaction

    Time frame: At 8 months

    Satisfaction score using validated telemedicine satisfaction survey (adapted from Tovar-Martínez et al.).

    Unit of Measure: Score (Likert scale).

  9. Adverse Effects

    Time frame: Baseline to 8 months

    Number of intervention-related adverse events. Unit of Measure: Count

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Institut Catala de Salut

Registry information

Official study title

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

Acronym: PTM

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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