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.
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
- Conditions the study is for
- Primary Health Care, Telemedicine, Face to Face Consultation
- What is being tested?
- Telemedicine Brief Behavioural Lifestyle Intervention and Face to face Brief Behavioural Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- 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- Outdated contact information.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
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.
- Conditions
- Primary Health Care, Telemedicine, Face to Face Consultation, Health Care Access, Prevention, Quality of Life
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 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.
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
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)
Smoking Status
Change in categorical smoking status (smoker/non-smoker). Unit of Measure: Categorical.
Measured: Baseline, 4 months, 8 months
Alcohol Consumption (AUDIT-C)
Change in score on the AUDIT-C questionnaire. Unit of Measure: Score (0-12).
Measured: Baseline, 4 months, 8 months
Mediterranean Diet Adherence (PREDIMED)
Change in PREDIMED score. Unit of Measure: Score (0-14).
Measured: 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)
Measured: 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)
Measured: Baseline, 4 months, 8 months
Coronary Risk (REGICOR Score)
Change in 10-year coronary risk percentage calculated using REGICOR function. Unit of Measure: Percentage (%),
Measured: 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.
Measured: 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).
Measured: At 8 months
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.
- First posted23 Dec 2025
- Study start25 Jun 2024
- Primary completion16 Jul 2025
- Study completion16 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Primary Health CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Catala de Salut
- Responsible party
- Principal investigator, Robert Panades Zafra, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- Josep Vidal Alaball, PhD, Study director, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaRobert Panadés Zafra, MD, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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 39190446Goncalves-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 32813281Direcció 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 26343551MSSSI, 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 35550977Rosembaun 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 29385118Estruch 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 29897866McGovern 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 20332401Littenberg 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 16872541Kruzich 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 14600311Equip 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 22427162Ramsay 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07299201
- Acronym / sponsor ID
- PTM / 23/282-P
- Conditions
- Primary Health Care, Telemedicine, Face to Face Consultation, Health Care Access, Prevention, Quality of Life
- Keywords
- telemedicine, primary care access, non-inferiority trial, health behavior change, rural healthcare, preventive medicine, quality of life, proactive intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Catala de Salut
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Mar 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Proactive Telemedicine (PTM) | Active comparator | Behavioral: Telemedicine Brief Behavioural Lifestyle InterventionParticipants 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. |
| Arm 2: Face-to-Face Consultation | Active comparator | Behavioral: Face to face Brief Behavioural Lifestyle InterventionParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine Brief Behavioural Lifestyle InterventionParticipants 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. | Behavioural | Arm 1: Proactive Telemedicine (PTM) |
| Face to face Brief Behavioural Lifestyle InterventionParticipants 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. | Behavioural | Arm 2: Face-to-Face Consultation |
Primary outcome
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 (%)
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)
9 secondary outcomes
Smoking Status
Time frame: Baseline, 4 months, 8 months
Alcohol Consumption (AUDIT-C)
Time frame: Baseline, 4 months, 8 months
Mediterranean Diet Adherence (PREDIMED)
Time frame: Baseline, 4 months, 8 months
Physical Activity (IPAQ)
Time frame: Baseline, 4 months, 8 months
Stage of Behavioral Change
Time frame: Baseline, 4 months, 8 months
Coronary Risk (REGICOR Score)
Time frame: Baseline and 8 months
Morbidity Assessment
Time frame: Baseline to 8 months
Patient Satisfaction
Time frame: At 8 months
Adverse Effects
Time frame: Baseline to 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 39190446Osman 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.
- Background: PubMed 32813281Goncalves-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.
- BackgroundDirecció General de Planificació en Salut. Document tècnic de l'Enquesta de salut de Catalunya 2021. Barcelona; 2022 Jun.
- Background: PubMed 26343551Flodgren 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.
- BackgroundMSSSI, 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.
- Background: PubMed 35550977Cordoba 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.
- Background: PubMed 29385118Rosembaun 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.
- Background: PubMed 29897866Estruch 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.
- BackgroundMcGovern 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.
- Background: PubMed 20332401Stringhini 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.
- Background: PubMed 16872541Littenberg 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.
- Background: PubMed 14600311Kruzich 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.
- Background resource on access to health services as a social determinant of health, from Healthy People 2030.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Primary Health Care
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Recruiting
Technology-Based Intervention Pilot Testing
Dementia, Elder Abuse
Not yet recruiting
Improving Colorectal Cancer Screening Uptake Through Education and Stool-Based Testing Outreach
Colorectal Cancer (CRC) Screening, CRC Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Vidal Alaball, PhD study director
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Robert Panadés Zafra, MD principal investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1 site in 1 country: see every site and its status.
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.