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

NCT07299201 | Active Not Recruiting

• 1 other identifier: 23/282-P
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

telemedicine; primary care access; non-inferiority trial; health behavior change; rural healthcare; preventive medicine; quality of life; proactive intervention

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• Smoking Status

  Baseline, 4 months, 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

Study Arms (2)

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.

Behavioral: Telemedicine Brief Behavioural Lifestyle Intervention

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

Behavioral: Face to face Brief Behavioural Lifestyle Intervention

Interventions

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.

Arm 1: Proactive Telemedicine (PTM)

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.

Arm 2: Face-to-Face Consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Institut Catala de Salut: collaborator

Study Sites (1)

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

Location

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Related Links

• Background resource on access to health services as a social determinant of health, from Healthy People 2030.

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Primary Care Physician, EAP Anoia Rural, Catalonia, Spain

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 23, 2025
• Study Start: June 25, 2024
• Primary Completion: July 16, 2025
• Study Completion: March 16, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)