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Complex Multiple Risk Behavior Intervention in People Between 45 to 75 Years (EIRA Study) (EIRA)

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ClinicalTrials.gov Identifier: NCT03136211
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : May 5, 2017
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Department of Health, Generalitat de Catalunya
Parc Sanitari Sant Joan de Déu
Sanidad de Castilla y León
Servei de Salut de les Illes Balears
Institut Català de la Salut
Servicio Aragonés de Salud
Osakidetza
Andaluz Health Service
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Servicio Galego de Saúde (SERGAS)
Information provided by (Responsible Party):
Bonaventura Bolíbar Ribas, Jordi Gol i Gurina Foundation

Brief Summary:
This study examines the effectiveness and the costs of a complex multiple risk behavior intervention to promote healthy behaviors in people aged between 45 and 75 years attended in Primary Health Care services. This intervention aims to reduce tobacco use, to enhance adherence to the Mediterranean dietary pattern and to increase physical activity. The study also seeks to provide evidence on the strategies to integrate health promotion into the usual clinical practice of primary care providers.

Condition or disease Intervention/treatment Phase
Health Behavior Health Promotion Primary Health Care Implementation Research Smoking Cessation Mediterranean Diet Physical Activity Behavioral: EIRA intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Hybrid Effectiveness-Implementation Trial of a Complex Multiple Risk Intervention to Promote Healthy Behaviors in People Between 45 to 75 Years Attended in Primary Health Care
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : November 30, 2018

Arm Intervention/treatment
Experimental: EIRA intervention
EIRA intervention It is based on the Transtheoretical Model (TTM) and States of Change and it is made by physicians and nurses in routine care of primary care practices according to the conceptual framework of the "5A": Ask, Advise, Assess, Assist, and Arrange. It consists of a first visit of screening ("Ask"). Subsequently, the professional develops a personalized plan that is negotiated with the participant ("Advise" and "Assess"). This plan is reviewed during successive visits and positive changes are reinforced and new objectives are negotiated ("Assist" and "Arrange"). The motivational interview is the essential tool of the intervention. The intervention is carried out to different levels: individual, group and community.
Behavioral: EIRA intervention
Individual intervention has an average intensity between 2 and 3 visits; if necessary, professionals have the freedom to make a greater number of visits. Group intervention is carried out through health education workshops. These workshops take place 15-20 days after initiating the individual intervention and they are conducted by primary care providers in the health center. A group of 12-15 people attend in each workshop. Community intervention focuses mainly on the social prescription of resources and activities that are carried out in the community where the participant person resides. In addition the intervention has the support of information and communication technologies, such as a web addressed to the participant, a mobile app or the sending personalized text messages.

No Intervention: Usual care
Health providers of this group integrate in their practice the recommendations of the Program of Preventive Activities and Health Promotion (PAPPS)". These guidelines are based on systematic screening and brief advice for the prevention of cardiovascular and mental diseases and cancer as well as vaccine recommendations.



Primary Outcome Measures :
  1. Effectiveness: Positive change in baseline eating behavior [ Time Frame: at the study entry and at 12 months ]
    Adherence to the Mediterranean dietary pattern in low adherence people. For the evaluation, the 14-item Questionnaire of Mediterranean diet adherence (PREDIMED study) will be used.

  2. Effectiveness: Positive change in baseline physical activity behavior [ Time Frame: at the study entry and at 12 months ]
    Sufficient physical activity in insufficiently active people. For the evaluation, the "International Physical Questionnaire (IPAQ)" will be used.

  3. Effectiveness: Positive change in baseline smoking behavior [ Time Frame: at the study entry and at 12 months ]
    Smoking cessation in smokers. For the evaluation, the interview will be used and the cooximetry (optional).

  4. Implementation: adoption [ Time Frame: Within 2 months prior to the start of the intervention ]
    Proportion of professionals who express their willingness to participate in the study between of total of potential professionals.

  5. Implementation: early acceptability [ Time Frame: Within 2 months prior to the start of the intervention ]
    They will be evaluated in professionals and participants by means of a survey.

  6. Implementation: final acceptability [ Time Frame: at 12 months post intervention ]
    They will be evaluated in professionals and participants by means of a survey. What is more, discussion groups will be held at the end of the intervention with the professionals and participants.

  7. Implementation: early appropriateness [ Time Frame: Within 2 months prior to the start of the intervention ]
    They will be evaluated in professionals and participants by means of a survey.

  8. Implementation: final appropriateness [ Time Frame: at 12 months post intervention ]
    They will be evaluated in professionals and participants by means of a survey. What is more, discussion groups will be held at the end of the intervention with the professionals and participants.

  9. Implementation: Cost of time invested in training and organizational meetings [ Time Frame: at 12 months post intervention ]
    Cost of time invested in training and organizational meetings to carry out the intervention.

  10. Implementation: feasibility [ Time Frame: at 12 months post intervention ]
    On the basis of the calculation of participation, recruitment and retention rate.

  11. Implementation: fidelity of the motivational interview technique [ Time Frame: Within 2 months prior to the start of the intervention ]
    The quality of the motivational interview will be evaluated through videotapes of visits to simulated patients through the "motivational interviewing assessment scale".

  12. Implementation: fidelity of the planned intervention [ Time Frame: at 12 months post intervention ]
    The degree of compliance of the activities recorded in the case report form will be analyzed.

  13. Implementation: penetration [ Time Frame: Within six months of the end of intervention ]
    The proportion of professionals who have integrated the intervention into their usual clinical practice within six months of the end of intervention.


Secondary Outcome Measures :
  1. Effectiveness: Beginning or making of a behavior change [ Time Frame: at the study entry and at 12 months ]
    Proportion of people who are in the stages of action, maintenance or termination according to the transtheoretical model at the entry and at the end of the study.

  2. Effectiveness: Change from baseline on arterial stiffness at 12 months [ Time Frame: at the study entry and at 12 months. ]
    Arterial stiffness assessed by the "Cardio-Ankle Vascular Index (CAVI)". CAVI will be measured in the routine clinical practice by the Vascular Screening System VaSera VS-1500N.

  3. Change from baseline on health-related quality of life [ Time Frame: at the study entry and at 12 months. ]
    Health-related quality of life as measured by the EuroQol-5D questionnaire.

  4. Change from baseline on costs of number visits, diagnostic tests, community resources used and loss of productivity [ Time Frame: at the study entry and at 12 months. ]
    Number in the last 12 monts of: primary-care and specialists visits, outpatient diagnostic tests, community resources used, group sessions attended and days off work per participant


Other Outcome Measures:
  1. Effectiveness: Reduction of the cardiovascular risk [ Time Frame: at the study entry and at 12 months ]
    Proportion of people with low/moderate and high/very high baseline cardiovascular risk who have reduced it by 10% and 25% respectively. Cardiovascular risk will be calculated using REGICOR and SCORE function charts.

  2. Effectiveness: Reduction of the risk of depression [ Time Frame: at the study entry and at 12 months ]
    Effect size greater than or equal to 8% in the probability of risk of depression in people with moderate to high risk of depression at the entry of study. People have received usual care will be compared to those who received the EIRA intervention. Risk of depression will be calculated using the algorithm PredictD.

  3. Effectiveness:change from baseline on body mass index [ Time Frame: at the study entry and at 12 months. ]
    Body mass index is defined as the body weight divided by the square of the body height, and is expressed in units of kg/m2.

  4. Effectiveness:change from baseline on waist circumference [ Time Frame: at the study entry and at 12 months. ]
    The waist circumference will be measured at a level midway between the lowest rib and the iliac crest. It will be expressed in units of cm.

  5. Effectiveness:change from baseline on blood pressure [ Time Frame: at the study entry and at 12 months. ]
    It will be measured in the routine clinical practice by validated electronic monitors and it will be expressed in units of mmHg.

  6. Effectiveness:change from baseline on lipid profile [ Time Frame: at the study entry and at 12 months. ]
    The lipid profile will include: low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and total cholesterol. They will be expressed in units of mg/dl.

  7. Effectiveness: change from baseline on ankle-brachial index [ Time Frame: at the study entry and at 12 months. ]
    It will be measured in the routine clinical practice by the Vascular Screening System VaSera VS-1500N.

  8. Effectiveness: change from baseline on the "REgicor and Artper Score fOr aNkle brachial index (REASON)" [ Time Frame: at the study entry and at 12 months. ]
    REASON is a validated screening test to select candidates for ankle-brachial index (ABI) measurement in the Spanish population. It uses clinical data routinely collected in general practice for cardiovascular risk estimation. This test integrates the following measures: personal history of hypercholesterolemia, diabetes mellitus, arterial hypertension, smoking, body mass index, blood pressure, glycaemia, total cholesterol, high density lipoprotein cholesterol (HDL-c), low density lipoprotein cholesterol (LDL-c), triglyceride, coronary heart disease risk using the Framingham function adapted to Spain and validated in this population and ABI measurement.

  9. Effectiveness: change from baseline on the perceived functional social support [ Time Frame: at the study entry and at 12 months. ]
    The questionnaire Duke-UNC-11 will be used to determine the perceived functional social support.

  10. Effectiveness: change from baseline on anxiety symptoms [ Time Frame: at the study entry and at 12 months. ]
    The General Anxiety Disorder-7 (GAD-7) questionnaire will be used to determine the prevalence and the severity of anxiety symptoms.

  11. Effectiveness: change from baseline on diet quality [ Time Frame: at the study entry and at 12 months. ]
    Diet Quality Index-International (DQI-I) will be used to determine diet quality.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • People who carry out 2 or more of the following unhealthy behaviors: tobacco consumption, low adherence to the Mediterranean dietary pattern or insufficient physical activity. In addition, they must have a professional provider of the health center assigned and voluntarily agree to participate.

Exclusion Criteria:

  • Advanced serious illnesses
  • Cognitive impairment
  • Dependence in basic everyday activities
  • Severe mental illness
  • People included in a long term home health care program
  • People in treatment for cancer
  • People in end-of-life care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136211


Contacts
Contact: Bonaventura Bolibar-Ribas, MD MSc 34 934 824 559 bbolibar@idiapjgol.org
Contact: Edurne Zabaleta-del-Olmo, RN MSc PhD 34 934 824 105 ezabaleta@idiapjgol.org

Locations
Spain
IDIAP Jordi Gol Recruiting
Barcelona, Spain
Contact: Bonaventura Bolibar-Ribas, MD MSc         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Instituto de Salud Carlos III
Department of Health, Generalitat de Catalunya
Parc Sanitari Sant Joan de Déu
Sanidad de Castilla y León
Servei de Salut de les Illes Balears
Institut Català de la Salut
Servicio Aragonés de Salud
Osakidetza
Andaluz Health Service
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Servicio Galego de Saúde (SERGAS)
Investigators
Principal Investigator: Bonaventura Bolibar-Ribas, MD MSc IDIAP Jordi Gol

Additional Information:
Publications of Results:

Other Publications:
Prestwich A, Webb TL, Conner M. Using theory to develop and test interventions to promote changes in health behaviour: Evidence, issues, and recommendations. Curr Opin Psychol. 2015;5:1-5.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bonaventura Bolíbar Ribas, redIAPP Coordinator, Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03136211     History of Changes
Other Study ID Numbers: 4R15/032
PI15/00114 ( Other Grant/Funding Number: Instituto de Salud Carlos III. Ministry of Economy, Industry and Competitiveness )
SLT002/16/00112 ( Other Grant/Funding Number: Department of Health of the Government of Catalonia. )
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No