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Adherence, MedicationNCT05094986

Feasibility and Acceptability of a Complex Intervention to Improve Initial Medication Adherence

A study testing Initial Medication Adherence (IMA) Intervention in people with Adherence, Medication, run by Fundació Sant Joan de Déu at 5 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot study aims to test the feasibility of the following effectiveness and cost-effectiveness evaluation using Real-World Data. 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) Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
605 participants
Where
5 sitesSpain
Study dates
1 Nov 2020to 30 Jun 2021
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 healthcare professionals and pharmacists who:
  • Agree to participate in the pilot study.
  • Primary care patients who:
  • Are prescribed a new treatment of cardiovascular disease o diabetes by a GP who participates in the clinical trial.
  • Are >18 years old.
  • Do not reject to participate.

Who cannot join

None listed.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Spain5 sites

  • CAP Cornellà de Llobregat (La Gavarra)

    Cornellà de Llobregat, Barcelona, 08940

  • Centro de Asistencia Primaria (CAP) Dr. Pujol i Capsada (CAP Pujol i Capsada)

    el Prat de Llobregat, Barcelona, 08820

  • CAP Dr. Bartomeu Fabrés Anglada Gava 2

    Gavà, Barcelona, 08850

  • CAP Florida Nord (CAP la Florida)

    L'Hospitalet de Llobregat, Barcelona, 08905

  • CAP Florida Sud (CAP la Florida)

    L'Hospitalet de Llobregat, Barcelona, 08905

Other trials in Spain

About this study

Official title: Pilot of a Complex Intervention to Improve Initial Medication Adherence to Cardiovascular and Diabetes Treatments in Primary Care

This pilot study aims to test the feasibility of the following effectiveness and cost-effectiveness evaluation using Real-World Data.

Read the detailed description

A cluster non-randomised pilot study with an embedded process evaluation was carried out to test the feasibility of the definitive cluster randomised controlled trial (cRCT). The cRCT will aim to evaluate the effectiveness and cost-effectiveness of the Initial Medication Adherence (IMA) intervention in comparison to usual care, to increase initiation of pharmacological treatments for CVD and diabetes (antihypertensive drugs, hypolipidemic drugs, antiplatelet drugs, and insulin and oral antidiabetics) prescribed in Primary Care (PC).

The pilot study was conducted in five PC centres (PCC) in Catalonia (Spain), two were assigned to the control group and three to the intervention group. There were two target participants, the implementation targeted professionals (general practitioners (GP), nurses, and community pharmacists), and the population targeted by the intervention, PC patients.

The IMA intervention provided healthcare professionals with the knowledge, skills, and tools to help the patient make an informed and shared decision with the GP to initiate a new CVD or diabetes treatment. Professionals were trained on the problem of non-initiation, communication skills, health literacy, and the use of decision aids (leaflets, website).

Being tested
Initial Medication Adherence (IMA) Intervention, Usual Care
Keywords
Pilot Study, Feasibility Study, 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) InterventionBehavioural

    The IMA intervention promotes health literacy and patient participation in the decision-making process during the recommendation and prescription of a new drug for the management of cardiovascular disease and diabetes. The IMA intervention has four main components: 1. Training for healthcare professionals (GPs, nurses, and community pharmacists) on non-initiation, shared-decision making, health literacy and use of decision aids; 2. Intervention support tools; decision aids (leaflets and website) and implementation tools (dispensing alert in community pharmacies when dispensing insulins and antiplatelet drugs); 3. Shared decision-making process during the GP's consultation; and 4. Information support provided by the nurses and community pharmacists that use the intervention decision aids to explore the patients' doubts and standardise the discourse between primary healthcare professionals.

  • Usual CareOther

    Patients received the usual care when being prescribed a new prescription for treatments of cardiovascular disease or diabetes. Nurses and community pharmacists were asked to also provide usual care to those patients. Community pharmacists from the control group had the dispensing alert available when dispensing insulins and antiplatelet drugs.

Study groups in NCT05094986
Study groupRoleWhat they receive
Intervention group: IMA InterventionExperimentalGeneral practitioners (GP) applied the IMA intervention to all patients receiving a new prescription for pharmacological treatments of cardiovascular disease or diabetes. Following the IMA intervention, nurses and community pharmacists offered information support in line with the information provided by the GP. Professionals had the intervention support tools available (leaflets, website and dispensing alert in community pharmacies).
Receives: Behavioral: Initial Medication Adherence (IMA) Intervention
Control groupActive comparatorHealthcare professionals from the control group prescribed medication and provided information as usual.
Receives: Other: Usual Care

What is being measured

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

  1. Rate of clinical registries related to diabetes mellitus II

    Rate of registries recorded five months before and after the prescription of:

    • Glycated haemoglobin
    • Glomerular filtrate
    • Blood glucose

    Measured: 5 months before and after recruitment

  2. Rate of clinical registries related to dyslipidemia

    Rate of registries recorded five months before and after the prescription of:

    • Total colesterol
    • HDL cholesterol
    • LDL colesterol

    Measured: 5 months before and after recruitment

  3. Rate of clinical registries related to hypertension

    Rate of registries recorded one to two months before and after the prescription of:

    • Systolic blood pressure
    • Diastolic blood pressure

    Measured: 2 months before and after recruitment

  4. Rate of clinical registries related to cardiovascular risk

    Rate of registries recorded five months before and after the prescription of:

    • REGICOR

    Measured: 5 months before and after recruitment

  5. Rate of use of services

    Rate of use of services recorded five months before and after the prescription of:

    • Visits to primary care (nurse, GP)
    • Referrals to secondary care
    • Productivity losses (sick leave days)
    • Outpatient diagnostic tests

    Measured: 5 months before and after recruitment

Secondary outcomes (3)

  1. Active diagnosis registry

    Proportion of patients with a new prescription of cardiovascular disease and diabetes treatments and an active diagnosis in the electronic system.

    Measured: 5 months before and after recruitment

  2. Missing registries

    Number of registries missing.

    Measured: 5 months before and after recruitment

  3. Outliers registries

    Number of registries with values out of their range.

    Measured: 5 months before and 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 posted26 Oct 2021
  2. Study start1 Nov 2020
  3. Primary completion30 Jan 2021
  4. Study completion30 Jun 2021

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
605 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05094986
Sponsor's protocol ID
19/198-P
Status last verified
Feb 2022
First submitted
8 Oct 2021
Last updated
18 Feb 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 in Catalonia. Consequently, meta-data cannot be published by the authors nor data can be identified with a DOI.

Publications

  • Corral-Partearroyo C, Sanchez-Vinas A, Gil-Girbau M, Penarrubia-Maria MT, Aznar-Lou I, Serrano-Blanco A, Carbonell-Duacastella C, Gallardo-Gonzalez C, Olmos-Palenzuela MDC, Rubio-Valera M. Improving Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care: Pilot trial of a complex intervention. Front Public Health. 2022 Dec 6;10:1038138. doi: 10.3389/fpubh.2022.1038138. eCollection 2022.

    PubMed 36561857

Questions about this trial

What is this clinical trial studying?

A study testing Initial Medication Adherence (IMA) Intervention in people with Adherence, Medication, run by Fundació Sant Joan de Déu at 5 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 6 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: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 clinical registries related to diabetes mellitus II (time frame: 5 months before and after recruitment). The study lists 5 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 NCT05094986, which also lists 1 linked publication.

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 18 Feb 2022.

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