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

Physical Activity Clinical Trial

— EIRA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136211
• Other study ID #: 4R15/032
• Secondary ID: PI15/00114SLT002
• Status: Completed
• Phase: N/A
• Start date: January 15, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2020
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Health promotion interventions are complex and need in-depth understanding of the context which is part of its effect. In this respect, the methodology proposed by the Medical Research Council offers a unique opportunity. This methodology proposes a development in five sequential phases in which both quantitative and qualitative methods are used, which include: a) definition of the theoretical basis (preclinical phase), b) modeling (phase I), c) exploratory trial (phase II), d) definitive randomized controlled trial (phase III) and e) long-term implementation (phase IV). This methodology promotes the participation of citizens and professionals in research and increases the acceptability and the feasibility of intervention. It is also an ideal tool to achieve the sustainability of interventions and the transfer of research to practice. Research on complex interventions marks a turning point in the conventional way of conducting experimental studies in which the most important thing is finding value and understanding the context of practice rather than trying to control its influence. Hybrid trials represent the ideal design because they allow a joint assessment of clinical effectiveness and implementation, thanks to their dual approach.

In this connection, the researchers started in 2012 the EIRA study and carried out the first three phases (preclinical phase, phase I and phase II). Currently, researchers are pursuing the phase III whose purpose is to assess the cost-effectiveness and the implementation of a health promotion intervention through a hybrid design.

This cluster randomized controlled trial aims to assess the effectiveness and the implementation of a complex multiple risk behavior intervention with two parallel groups (intervention and usual care). It is based on:

• The "Consolidated Framework for Implementation Research" (CFIR) which identifies five constructs: 1) intervention characteristics (intervention source, evidence strength and quality, relative advantage, adaptability, trialability, complexity, design quality and packaging; and cost); 2) outer setting (patient needs and resources, cosmopolitanism, peer pressure, and external policy and incentives); 3) inner setting (structural characteristics, networks and communications, culture, implementation climate and readiness for implementation); 4) characteristics of individuals (knowledge and beliefs about the intervention, self-efficacy, individual state of change, individual identification with the organization, and other personal attributes); and 5) the implementation process itself.

• A set of discrete implementation strategies which includes: plan strategies (gather information, adapt and pilot material and processes, build buy-in, initiate leadership and develop relationships); educate strategies (develop materials, educate, educate through peers, inform and influence stakeholders); finance strategies (modify incentives and facilitate financial support); restructure strategies (revise professional roles and create community and group interventions committees) and quality management strategies (develop and organize implementation monitoring systems, conduct continuous assessment and feedback, establish a system of reminders, obtain and use patient opinion, centralize technical assistance focused on implementation issues).

• An evaluation framework to determine the success of implementation.

The study will be carried out in three stages:

STAGE 1: PRE-IMPLEMENTATION. During this stage, the researchers will assess local needs and resources to develop specific implementation strategies. Likewise, the scientific literature will be reviewed and the perspectives of clinicians on the internal resources will be measured by the "Survey of Organizational Attributes for Primary Care". All the support material for the intervention will be drawn up, besides the facilitator (member of the research team) and the leader (member of the primary care team) of the implementation will be designated. Mechanisms for the effective communication and the case report form (CRF) will be defined and piloted. Formal compromises will be made with the managers (at the macro, meso and micro levels) and with the professionals involved. Training activities will be carried out in which training in motivational interview will have a central role. In addition, a checklist (on-line database) will be developed and piloted to monitor the progress of implementation in each primary care center.

STAGE 2: IMPLEMENTATION. In this stage the implementation plan will be carried out. The facilitator and the leader of implementation will monitor the implementation processes, identify opportunities for improvement and optimize implementation. Likewise, positive feedback techniques will be used towards the main stakeholders in order to keep the agreed compromise and the motivation. Besides, health professionals will receive continuous training in motivational interview.

STAGE 3: POST-IMPLEMENTATION.

The evaluation of the implementation will be carried out through qualitative and quantitative research. It will be evaluated in terms of:

A) OUTCOMES (see section "Outcome Measures"). B) DETERMINANTS. Three focus groups (one of health professionals and two of participants) will be conducted in each health center. Sampling will be theoretical (discursive plurality). Sessions will be transcribed in an anonymous fashion. A thematic content analysis will be done. The CFIR constructs will be scored following standard criteria that they will reflect the influence of the construct on the implementation (positive or negative) and its magnitude (between 1 and 2).

C) LEVEL OF DEVELOPMENT. The level of development of each of the implementation strategies will be determined from the online database. Updating of this database will be carried out by the facilitator of implementation. Likewise, logistic regression models will be developed in which the dependent variable will be the effectiveness of the intervention, considered as a positive change in any of the three behaviors studied. In one of the models the independent variables will be the quantitative measures of the results of the implementation and in the other, the degree of implementation of the different strategies. The purpose of these analyzes is to model the relationship between the implementation variables and those of effectiveness. On the other hand, the influence and the magnitude of the determinants of the implementation and the results will be established through multivariate models.

SAMPLE SIZE It will be necessary to study a minimum of 3640 people (1820 for each of the two groups). This sample size will allow to detect an increase of 8% in the proportion of people who show a positive change in one or more of the three behaviors in the intervention group over control group. The proportion of losses during follow-up estimated was of 30%. The sample size was decided taking into account the effect of design (intraclass correlation coefficient of 0.01).The power was 80% and alpha risk 5%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3062
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior
• Health Promotion
• Implementation Research
• Mediterranean Diet
• Physical Activity
• Primary Health Care
• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
Spain	IDIAP Jordi Gol	Barcelona

Sponsors (12)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Andaluz Health Service, Department of Health, Generalitat de Catalunya, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud, Institut Català de la Salut, Instituto de Salud Carlos III, Osakidetza, Parc Sanitari Sant Joan de Déu, Sanidad de Castilla y León, Servei de Salut de les Illes Balears, Servicio Aragonés de Salud, Servicio Galego de Saúde (SERGAS)

Country where clinical trial is conducted

Spain, 

References & Publications (28)

Álvarez-Bueno C, Cavero-Redondo I, Martínez-Andrés M, Arias-Palencia N, Ramos-Blanes R, Salcedo-Aguilar F. Effectiveness of multifactorial interventions in primary health care settings for primary prevention of cardiovascular disease: A systematic review — View Citation

Álvarez-Bueno C, Rodríguez-Martín B, García-Ortiz L, Gómez-Marcos MÁ, Martínez-Vizcaíno V. Effectiveness of brief interventions in primary health care settings to decrease alcohol consumption by adult non-dependent drinkers: a systematic review of systema — View Citation

Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, Robertson N, Wensing M, Fiander M, Eccles MP, Godycki-Cwirko M, van Lieshout J, Jäger C. Tailored interventions to address determinants of practice. Cochrane Database Syst Rev. 2015 Apr 29;(4):CD005470. doi: 10.1002/14651858.CD005470.pub3. Review. — View Citation

Bellón JÁ, Moreno-Peral P, Motrico E, Rodríguez-Morejón A, Fernández A, Serrano-Blanco A, Zabaleta-del-Olmo E, Conejo-Cerón S. Effectiveness of psychological and/or educational interventions to prevent the onset of episodes of depression: A systematic rev — View Citation

Berenguera A, Pons-Vigués M, Moreno-Peral P, March S, Ripoll J, Rubio-Valera M, Pombo-Ramos H, Asensio-Martínez A, Bolaños-Gallardo E, Martínez-Carazo C, Maderuelo-Fernández JÁ, Martínez-Andrés M, Pujol-Ribera E. Beyond the consultation room: Proposals to — View Citation

Bully P, Sánchez Á, Zabaleta-del-Olmo E, Pombo H, Grandes G. Evidence from interventions based on theoretical models for lifestyle modification (physical activity, diet, alcohol and tobacco use) in primary care settings: A systematic review. Prev Med. 201 — View Citation

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655. — View Citation

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. — View Citation

Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50. — View Citation

Fernandez A, Moreno-Peral P, Zabaleta-del-Olmo E, Bellon JA, Aranda-Regules JM, Luciano JV, Serrano-Blanco A, Rubio-Valera M. Is there a case for mental health promotion in the primary care setting? A systematic review. Prev Med. 2015 Jul;76 Suppl:S5-11. — View Citation

García-Campayo J, del Hoyo YL, Valero MS, Yus MC, Esteban EA, Guedea MP, Botaya RM. Primary prevention of anxiety disorders in primary care: A systematic review. Prev Med. 2015 Jul;76 Suppl:S12-5. doi: 10.1016/j.ypmed.2014.10.015. Epub 2014 Oct 16. Review — View Citation

Gili M, Vicens C, Roca M, Andersen P, McMillan D. Interventions for preventing relapse or recurrence of depression in primary health care settings: A systematic review. Prev Med. 2015 Jul;76 Suppl:S16-21. doi: 10.1016/j.ypmed.2014.07.035. Epub 2014 Sep 3. — View Citation

Lin JS, O'Connor E, Evans CV, Senger CA, Rowland MG, Groom HC. Behavioral counseling to promote a healthy lifestyle in persons with cardiovascular risk factors: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2014 Oct 21;161(8):568-78. doi: 10.7326/M14-0130. Review. — View Citation

Maderuelo-Fernandez JA, Recio-Rodríguez JI, Patino-Alonso MC, Pérez-Arechaederra D, Rodriguez-Sanchez E, Gomez-Marcos MA, García-Ortiz L. Effectiveness of interventions applicable to primary health care settings to promote Mediterranean diet or healthy ea — View Citation

March S, Torres E, Ramos M, Ripoll J, García A, Bulilete O, Medina D, Vidal C, Cabeza E, Llull M, Zabaleta-del-Olmo E, Aranda JM, Sastre S, Llobera J. Adult community health-promoting interventions in primary health care: A systematic review. Prev Med. 20 — View Citation

Martín Cantera C, Puigdomènech E, Ballvé JL, Arias OL, Clemente L, Casas R, Roig L, Pérez-Tortosa S, Díaz-Gete L, Granollers S. Effectiveness of multicomponent interventions in primary healthcare settings to promote continuous smoking cessation in adults: — View Citation

Moreno-Peral P, Conejo-Cerón S, Fernández A, Berenguera A, Martínez-Andrés M, Pons-Vigués M, Motrico E, Rodríguez-Martín B, Bellón JA, Rubio-Valera M. Primary care patients' perspectives of barriers and enablers of primary prevention and health promotion- — View Citation

Morton K, Beauchamp M, Prothero A, Joyce L, Saunders L, Spencer-Bowdage S, Dancy B, Pedlar C. The effectiveness of motivational interviewing for health behaviour change in primary care settings: a systematic review. Health Psychol Rev. 2015;9(2):205-23. doi: 10.1080/17437199.2014.882006. Epub 2014 Feb 12. Review. — View Citation

Pons-Vigués M, Berenguera A, Coma-Auli N, March S, Pombo H, Masluk B, Pulido-Fuentes M, Rodriguez C, Bellón JA, Pujol-Ribera E. Qualitative evaluation of a complex intervention to implement health promotion activities according to healthcare attendees and — View Citation

Pons-Vigués M, Berenguera A, Coma-Auli N, Pombo-Ramos H, March S, Asensio-Martínez A, Moreno-Peral P, Mora-Simón S, Martínez-Andrés M, Pujol-Ribera E. Health-care users, key community informants and primary health care workers' views on health, health pro — View Citation

Powell BJ, McMillen JC, Proctor EK, Carpenter CR, Griffey RT, Bunger AC, Glass JE, York JL. A compilation of strategies for implementing clinical innovations in health and mental health. Med Care Res Rev. 2012 Apr;69(2):123-57. doi: 10.1177/1077558711430690. Epub 2011 Dec 26. Review. — View Citation

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.

Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. — View Citation

Ramos R, Baena-Díez JM, Quesada M, Solanas P, Subirana I, Sala J, Alzamora M, Forès R, Masiá R, Elosua R, Grau M, Cordón F, Pera G, Rigo F, Martí R, Ponjoan A, Cerezo C, Brugada R, Marrugat J. Derivation and validation of REASON: a risk score identifying candidates to screen for peripheral arterial disease using ankle brachial index. Atherosclerosis. 2011 Feb;214(2):474-9. doi: 10.1016/j.atherosclerosis.2010.11.015. Epub 2010 Nov 19. — View Citation

Rubio-Valera M, Pons-Vigués M, Martínez-Andrés M, Moreno-Peral P, Berenguera A, Fernández A. Barriers and facilitators for the implementation of primary prevention and health promotion activities in primary care: a synthesis through meta-ethnography. PLoS — View Citation

Sanchez A, Bully P, Martinez C, Grandes G. Effectiveness of physical activity promotion interventions in primary care: A review of reviews. Prev Med. 2015 Jul;76 Suppl:S56-67. doi: 10.1016/j.ypmed.2014.09.012. Epub 2014 Sep 26. Review. — View Citation

Zabaleta-del-Olmo E, Bolibar B, García-Ortíz L, García-Campayo J, Llobera J, Bellón JÁ, Ramos R. Building interventions in primary health care for long-term effectiveness in health promotion and disease prevention. A focus on complex and multi-risk interv — View Citation

Zabaleta-Del-Olmo E, Pombo H, Pons-Vigués M, Casajuana-Closas M, Pujol-Ribera E, López-Jiménez T, Cabezas-Peña C, Martín-Borràs C, Serrano-Blanco A, Rubio-Valera M, Llobera J, Leiva A, Vicens C, Vidal C, Campiñez M, Martín-Álvarez R, Maderuelo JÁ, Recio J — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effectiveness: Reduction of the cardiovascular risk	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.	at the study entry and at 12 months
Other	Effectiveness: Reduction of the risk of depression	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.	at the study entry and at 12 months
Other	Effectiveness:change from baseline on body mass index	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.	at the study entry and at 12 months.
Other	Effectiveness:change from baseline on waist circumference	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.	at the study entry and at 12 months.
Other	Effectiveness:change from baseline on blood pressure	It will be measured in the routine clinical practice by validated electronic monitors and it will be expressed in units of mmHg.	at the study entry and at 12 months.
Other	Effectiveness:change from baseline on lipid profile	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.	at the study entry and at 12 months.
Other	Effectiveness: change from baseline on ankle-brachial index	It will be measured in the routine clinical practice by the Vascular Screening System VaSera VS-1500N.	at the study entry and at 12 months.
Other	Effectiveness: change from baseline on the "REgicor and Artper Score fOr aNkle brachial index (REASON)"	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.	at the study entry and at 12 months.
Other	Effectiveness: change from baseline on the perceived functional social support	The questionnaire Duke-UNC-11 will be used to determine the perceived functional social support.	at the study entry and at 12 months.
Other	Effectiveness: change from baseline on anxiety symptoms	The General Anxiety Disorder-7 (GAD-7) questionnaire will be used to determine the prevalence and the severity of anxiety symptoms.	at the study entry and at 12 months.
Other	Effectiveness: change from baseline on diet quality	Diet Quality Index-International (DQI-I) will be used to determine diet quality.	at the study entry and at 12 months.
Primary	Effectiveness: Positive change in baseline eating behavior	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.	at the study entry and at 12 months
Primary	Effectiveness: Positive change in baseline physical activity behavior	Sufficient physical activity in insufficiently active people. For the evaluation, the "International Physical Questionnaire (IPAQ)" will be used.	at the study entry and at 12 months
Primary	Effectiveness: Positive change in baseline smoking behavior	Smoking cessation in smokers. For the evaluation, the interview will be used and the cooximetry (optional).	at the study entry and at 12 months
Primary	Implementation: adoption	Proportion of professionals who express their willingness to participate in the study between of total of potential professionals.	Within 2 months prior to the start of the intervention
Primary	Implementation: early acceptability	They will be evaluated in professionals and participants by means of a survey.	Within 2 months prior to the start of the intervention
Primary	Implementation: final acceptability	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.	at 12 months post intervention
Primary	Implementation: early appropriateness	They will be evaluated in professionals and participants by means of a survey.	Within 2 months prior to the start of the intervention
Primary	Implementation: final appropriateness	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.	at 12 months post intervention
Primary	Implementation: Cost of time invested in training and organizational meetings	Cost of time invested in training and organizational meetings to carry out the intervention.	at 12 months post intervention
Primary	Implementation: feasibility	On the basis of the calculation of participation, recruitment and retention rate.	at 12 months post intervention
Primary	Implementation: fidelity of the motivational interview technique	The quality of the motivational interview will be evaluated through videotapes of visits to simulated patients through the "motivational interviewing assessment scale".	Within 2 months prior to the start of the intervention
Primary	Implementation: fidelity of the planned intervention	The degree of compliance of the activities recorded in the case report form will be analyzed.	at 12 months post intervention
Primary	Implementation: penetration	The proportion of professionals who have integrated the intervention into their usual clinical practice within six months of the end of intervention.	Within six months of the end of intervention
Secondary	Effectiveness: Beginning or making of a behavior change	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.	at the study entry and at 12 months
Secondary	Effectiveness: Change from baseline on arterial stiffness 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.	at the study entry and at 12 months.
Secondary	Change from baseline on health-related quality of life	Health-related quality of life as measured by the EuroQol-5D questionnaire.	at the study entry and at 12 months.
Secondary	Change from baseline on costs of number visits, diagnostic tests, community resources used and loss of productivity	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	at the study entry and at 12 months.

External Links

•   EIRA study website