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Primary Health CarePTMNCT07299201

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

A study testing Telemedicine Brief Behavioural Lifestyle Intervention and Face to face Brief Behavioural Lifestyle Intervention in people with Primary Health Care and Telemedicine, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Telemedicine Brief Behavioural Lifestyle Intervention and Face to face Brief Behavioural Lifestyle Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSpain
Study dates
25 Jun 2024to 16 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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  • Outdated contact information.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • 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

Other trials in Spain

About this study

Official 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

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.

Read the 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.

Being tested
Telemedicine Brief Behavioural Lifestyle Intervention, Face to face Brief Behavioural Lifestyle Intervention
Keywords
telemedicine, primary care access, non-inferiority trial, health behavior change, rural healthcare, preventive medicine, quality of life, proactive intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine Brief Behavioural Lifestyle InterventionBehavioural

    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 InterventionBehavioural

    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.

Study groups in NCT07299201
Study groupRoleWhat they receive
Arm 1: Proactive Telemedicine (PTM)Active comparatorParticipants 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.
Receives: Behavioral: Telemedicine Brief Behavioural Lifestyle Intervention
Arm 2: Face-to-Face ConsultationActive comparatorParticipants 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
Receives: Behavioral: Face to face Brief Behavioural Lifestyle Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (%)

    Measured: 12-month post-intervention

  2. 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)

    Measured: Baseline, 4 months, 8 months

Secondary outcomes (9)
  1. Smoking Status

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

    Measured: Baseline, 4 months, 8 months

  2. Alcohol Consumption (AUDIT-C)

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

    Measured: Baseline, 4 months, 8 months

  3. Mediterranean Diet Adherence (PREDIMED)

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

    Measured: Baseline, 4 months, 8 months

  4. Physical Activity (IPAQ)

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

    Measured: Baseline, 4 months, 8 months

  5. Stage of Behavioral Change

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

    Measured: Baseline, 4 months, 8 months

  6. Coronary Risk (REGICOR Score)

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

    Measured: Baseline and 8 months

  7. Morbidity Assessment

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

    Unit of Measure: Count of conditions.

    Measured: Baseline to 8 months

  8. Patient Satisfaction

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

    Unit of Measure: Score (Likert scale).

    Measured: At 8 months

  9. Adverse Effects

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

    Measured: Baseline to 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2025
  2. Study start25 Jun 2024
  3. Primary completion16 Jul 2025
  4. Study completion16 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07299201
Sponsor's protocol ID
23/282-P
Acronym
PTM
Status last verified
Nov 2025
First submitted
26 Nov 2025
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39190446
  • 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.

    PubMed 32813281
  • Direcció General de Planificació en Salut. Document tècnic de l'Enquesta de salut de Catalunya 2021. Barcelona; 2022 Jun.

  • Flodgren G, Rachas A, Farmer AJ, Inzitari M, Shepperd S. Interactive telemedicine: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2015 Sep 7;2015(9):CD002098. doi: 10.1002/14651858.CD002098.pub2.

    PubMed 26343551
  • MSSSI, 2015. Consejo integral en estilo de vida en atención primaria, vinculado con recursos comunitarios en población adulta. Estrategia de Promoción de la Salud y Prevención en el SNS. Ministerio de Sanidad, Servicios Sociales e Igualdad. Madrid; 2015.

  • Cordoba Garcia R, Camarelles Guillem F. [Screening and brief intervention on alcohol consumption]. Aten Primaria. 2022 Jul;54(7):102349. doi: 10.1016/j.aprim.2022.102349. Epub 2022 May 9. Spanish.

    PubMed 35550977
  • Rosembaun A, Rojas P, Rodriguez MV, Barticevic N, Rivera Mercado S. Brief interventions to promote behavioral change in primary care settings, a review of their effectiveness for smoking, alcohol and physical inactivity. Medwave. 2018 Jan 29;18(1):e7148. doi: 10.5867/medwave.2018.01.7148. English, Spanish.

    PubMed 29385118
  • Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.

    PubMed 29897866
  • McGovern L, Miller G, Hughes-Cromwick P. The Relative Contribution of Multiple Determinants to Health Outcomes. Researchers continue to study the many interconnected factors that affect people's health. Heal Policy Br. 2014 Aug 21;1-9.

  • Stringhini S, Sabia S, Shipley M, Brunner E, Nabi H, Kivimaki M, Singh-Manoux A. Association of socioeconomic position with health behaviors and mortality. JAMA. 2010 Mar 24;303(12):1159-66. doi: 10.1001/jama.2010.297.

    PubMed 20332401
  • Littenberg B, Strauss K, MacLean CD, Troy AR. The use of insulin declines as patients live farther from their source of care: results of a survey of adults with type 2 diabetes. BMC Public Health. 2006 Jul 27;6:198. doi: 10.1186/1471-2458-6-198.

    PubMed 16872541
  • Kruzich JM, Jivanjee P, Robinson A, Friesen BJ. Family caregivers' perceptions of barriers to and supports of participation in their children's out-of-home treatment. Psychiatr Serv. 2003 Nov;54(11):1513-8. doi: 10.1176/appi.ps.54.11.1513.

    PubMed 14600311
  • Equip ESCA del Departament de Salut. Document tècnic de l ' Enquesta de salut de Catalunya (ESCA). Barcelona; 2016.

  • Benachi Sandoval N, Castillo Martinez A, Vilaseca Llobet JM, Torres Belmonte S, Risco Vilarasau E. [Validation of the Spanish version of the Primary Care Assessment Survey questionnaire]. Rev Panam Salud Publica. 2012 Jan;31(1):32-9. doi: 10.1590/s1020-49892012000100005. Spanish.

    PubMed 22427162
  • Ramsay J, Campbell JL, Schroter S, Green J, Roland M. The General Practice Assessment Survey (GPAS): tests of data quality and measurement properties. Fam Pract. 2000 Oct;17(5):372-9. doi: 10.1093/fampra/17.5.372.

    PubMed 11021894

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine Brief Behavioural Lifestyle Intervention and Face to face Brief Behavioural Lifestyle Intervention in people with Primary Health Care and Telemedicine, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Access to Primary Healthcare (time frame: 12-month post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07299201, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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