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Adherence, MedicationIMA-cRCTNCT05026775

Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention

A study testing Initial Medication Adherence (IMA) in people with Adherence, Medication, run by Fundació Sant Joan de Déu at 24 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess the effectiveness and the cost-effectiveness of the Initial Medication Adherence (IMA) Intervention. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adherence, Medication
What is being tested?
Initial Medication Adherence (IMA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,153 participants
Where
24 sitesSpain
Study dates
1 Mar 2022to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary Care health professionals and pharmacists who:
  • Agree to participate in the clinical trial and process evaluation.
  • Attend the training course
  • Are not plannig to be on sick leave during the study period (e.g. maternity leave).
  • Patients who:
  • Are prescribed a new treatment of cardiovascular disease o diabetes by a doctor who participates in the clinical trial.
  • Are >18 years old
  • Do not reject to participate

Who cannot join

None listed.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Spain24 sites

  • CAP Drassanes

    Barcelona, 08001

  • CAP Horta

    Barcelona, 08032

  • CAP La Marina

    Barcelona, 08038

  • CAP Pou Torre

    Begues, Barcelona, 08859

  • CAP Calaf

    Calaf, Barcelona, 08280

  • CAP Corbera de Llobregat

    Corbera de Llobregat, Barcelona, 08757

  • CAP Cornudella de Montsant

    Cornudella de Montsant, Tarragona, 43360

  • CAP Montilivi

    Girona, 17003

  • CAP La Llagosta

    La Llagosta, Barcelona, 08120

  • CAP Martorell

    Martorell, Barcelona, 08760

  • CAP Montcada i Reixac

    Montcada i Reixac, Barcelon, 08110

  • CAP Montornès del Vallès

    Montornès del Vallès, Barcelona, 08170

  • CAP Sant Pere

    Reus, Tarragona, 43202

  • CAP Ripollet

    Ripollet, Barcelona, 08291

  • CAP Vinyets

    Sant Boi de Llobregat, Barcelona, 08830

  • Parc Sanitari Sant Joan de Déu

    Sant Boi de Llobregat, Barcelona, 08830

  • CAP Sant Sadurni d'Anoia

    Sant Sadurní d'Anoia, Barcelona, 08770

  • CAP Sant Vicenç de Castellet

    Sant Vicenç de Castellet, Barcelona, 08295

  • CAP Santa Coloma de Queralt

    Santa Coloma de Queralt, Tarragona, 43420

  • CAP Sitges

    Sitges, Barcelona, 08870

  • CAP Sort

    Sort, Lleida, 25560

  • CAP Sant Pere i Sant Pau

    Tarragona, 43007

  • CAP Bonavista

    Tarragona, 43100

  • CAP de Tremp

    Tremp, Lleida, 25620

Other trials in Spain

About this study

Official title: Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention: Cluster-randomized Controlled Trial and Economic Model

The purpose of this study is to assess the effectiveness and the cost-effectiveness of the Initial Medication Adherence (IMA) Intervention.

Read the detailed description

A pragmatic cluster randomised control trial will be conducted to evaluate the effectiveness of the IMA intervention in comparison to usual care, in the increase of initiation of medicines for CVD and diabetes (antihypertensive, lipid-lowering, antidiabetic and antiplatelet medications) prescribed in Primary Care (PC). The impact of the IMA intervention on secondary adherence and clinical indicators will be evaluated.

A multicenter pragmatic RCT, with cluster allocation and 2 parallel branches (IMA intervention vs. usual care) based on health records or RWD will be conducted.

PC centres' personnel, including general practitioners (GP), nurses and community pharmacists, from different areas around Catalonia (Spain), will be cluster randomised 1:1 into intervention and control groups, stratified according to the type of PC centre, either rural or urban and taking into consideration the size and localization of the PC centre and the main predictors of non-initiation (socioeconomic status, mean age, % immigrant population of the PC centre).

The IMA intervention will provide clinicians with knowledge, skills and tools to help the patient make an informed decision. PC centre personnel in the intervention group will receive training on medication non-initiation, communication abilities, health literacy, shared decision making and the use of support tools such as leaflets and the IMA website.

Being tested
Initial Medication Adherence (IMA), Usual care
Keywords
Complex Intervention, Real World Data, Cardiovascular Disease, Diabetes Mellitus
Medical subject headings
Medication Adherence, Cardiovascular Diseases, Diabetes Mellitus

What participants receive

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

  • Initial Medication Adherence (IMA)Behavioural

    The IMA intervention is a shared-decision making intervention that promotes health literacy and patient participation in the decision making process during the recommendation and prescription of a new drug for the management of a cardiovascular disease and diabetes.

    The IMA intervention has four main components: training for healthcare professionals (general practitioners (GP), nurses and community pharmacists) on non-initiation, shared-decision making, health literacy and use of decision aids; intervention decision aids (leaflets and website); implementation of the IMA intervention during the GP's consultation; and information support provided by the nurses and community pharmacists that will use the intervention decision aids to explore the patients's doubts and harmonise and standardise the discourse between primary healthcare professionals.

  • Usual careOther

    Health professionals in the usual care group will prescribe medication and provide information as usual.

Study groups in NCT05026775
Study groupRoleWhat they receive
Initial Medication Adherence (IMA) interventionExperimentalGeneral practitioners (GP) will apply the IMA intervention to all patients receiving a new prescription for treatment of cardiovascular disease or diabetes. Following the IMA intervention, nurses and community pharmacists will offer information support in line with the information provided by the GP.
Receives: Behavioral: Initial Medication Adherence (IMA)
Usual careActive comparatorPatients will receive the usual care when being prescribed a new prescription for treatment of cardiovascular disease or diabetes. Nurses and community pharmacists will be asked to also provide usual care to those patients.
Receives: Other: Usual care

What is being measured

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

  1. Rate of Initiation

    Patients who receive a new prescription (a prescription is considered new if there is no previouos prescription from the same group in the previous 6 months) will be considered initiators if they fill-up their prescription in the community pharmacy.

    Prescription and dispensation databases will be compared to classify prescriptions as initiated and non-initiated.

    Measured: 1 month and 3 months after recruitment

Secondary outcomes (2)

  1. Rate of adherence

    Adherence will be calculated based on the Medication Possesion Ratio (MPR is the sum of the days' supply for all fills of a given drug in a particular time period, divided by the number of days in the time period).

    Measured: 1 year after recruitment

  2. Reduction of Cardiovascular Risk

    Framingham risk score will be calculated.

    Measured: 1 year after recruitment

Timeline

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

  1. First posted30 Aug 2021
  2. Study start1 Mar 2022
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2023 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4,153 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05026775
Sponsor's protocol ID
948973
Acronym
IMA-cRCT
Status last verified
Oct 2022
First submitted
23 Jul 2021
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The research team is not the data owner as they are only re-using information that is the property of the public health institutions. Consequently, meta-data cannot be published by the authors nor data can be identified with a DOI.

Publications

  • Corral-Partearroyo C, Sanchez-Vinas A, Aznar-Lou I, Penarrubia-Maria MT, Gil-Girbau M, Gallardo-Gonzalez C, Olmos-Palenzuela MDC, Rubio-Valera M. Effectiveness of a patient-centred complex intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): a pragmatic cluster randomised controlled trial using real-world data. BMJ Qual Saf. 2025 Jul 1:bmjqs-2024-018402. doi: 10.1136/bmjqs-2024-018402. Online ahead of print.

    PubMed 40592577

  • Corral-Partearroyo C, Sanchez-Vinas A, Penarrubia-Maria MT, Gil-Girbau M, Aznar-Lou I, Palma-Vasquez C, Gallardo-Gonzalez C, Olmos-Palenzuela MDC, Rubio-Valera M. Implementation of a patient-centred complex intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): a mixed-methods process evaluation. BMJ Qual Saf. 2025 Jun 8:bmjqs-2024-018403. doi: 10.1136/bmjqs-2024-018403. Online ahead of print.

    PubMed 40484629

  • Corral-Partearroyo C, Sanchez-Vinas A, Gil-Girbau M, Penarrubia-Maria MT, Aznar-Lou I, Gallardo-Gonzalez C, Olmos-Palenzuela MDC, Rubio-Valera M. Complex multidisciplinary intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): mixed-methods process evaluation protocol. BMJ Open. 2022 Oct 31;12(10):e067468. doi: 10.1136/bmjopen-2022-067468.

    PubMed 36316078

  • Sanchez-Vinas A, Corral-Partearroyo C, Gil-Girbau M, Penarrubia-Maria MT, Gallardo-Gonzalez C, Olmos-Palenzuela MD, Aznar-Lou I, Serrano-Blanco A, Rubio-Valera M. Effectiveness and cost-effectiveness of an intervention to improve Initial Medication Adherence to treatments for cardiovascular diseases and diabetes in primary care: study protocol for a pragmatic cluster randomised controlled trial and economic model (the IMA-cRCT study). BMC Prim Care. 2022 Jul 5;23(1):170. doi: 10.1186/s12875-022-01727-6.

    PubMed 35790915

Questions about this trial

What is this clinical trial studying?

A study testing Initial Medication Adherence (IMA) in people with Adherence, Medication, run by Fundació Sant Joan de Déu at 24 sites 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 8 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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?

Results are not available in the source record.

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?

Rate of Initiation (time frame: 1 month and 3 months after recruitment). 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 NCT05026775, which also lists 4 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 12 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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