Medication AdherenceNCT04662762
A Nursing Intervention Program to Improve Therapeutic Adherence in Elderly People With Acute Myocardial Infarction
A study testing Nursing intervention programme in people with Medication Adherence and Myocardial Infarction, run by Hospital Universitari de Bellvitge.
Trial summary
The objective of this study was to assess the impact of a nursing intervention on therapeutic adherence in elderly patients after acute myocardial infarction compared to a control group Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Medication Adherence, Myocardial Infarction
- What is being tested?
- Nursing intervention programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 28 May 2020
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with STEMI aged 75 years or older underwent primary percutaneous coronary intervention (PCI)
Who cannot join
- Patients who refused to participate in the study
- Patients unable to perform geriatric assessment.
- Patients admitted to nursing homes or social health centres.
About this study
Official title: A Nursing Intervention Program Significantly Improves Therapeutic Adherence in Elderly People With Acute Myocardial Infarction: a Randomized Controlled Study
The objective of this study was to assess the impact of a nursing intervention on therapeutic adherence in elderly patients after acute myocardial infarction compared to a control group
Read the detailed description
A comprehensive geriatric assessment was performed during the first admission in all patients. Patients were randomly allocated to a nursing intervention group or a usual care group. In patients from the intervention group, a nursing intervention programme was performed 3 months after admission, based on education, support and patient monitoring to improve therapeutic adherence and a 6 month phone call. The main outcome measured was therapeutic adherence at 12 months, as defined by a combination of adherence measurement tools (Morisky-Green and Hayness-Sacket scales, attendance at visits and withdrawal of medication from the pharmacy). Therapeutic adherence was assessed by nurses blinded to the assignment group.
- Conditions
- Medication Adherence, Myocardial Infarction
- Being tested
- Nursing intervention programme
- Keywords
- Elderly, Nursing
- Medical subject headings
- Medication Adherence, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing intervention programmeOther
educational information
| Study group | Role | What they receive |
|---|---|---|
| nursing intervention group | Experimental | An educational interview by trained nurses was performed at three months in patients allocated to the intervention group. The visit was carried out at the hospital. Family and caregivers were also asked to attend this visit for instruction. For patients unable to move, the nursing team went to their home to perform the intervention, or it was conducted by phone. The duration of this interview was approximately 40 minutes and was focused on some measures and recommendations to improve or maintain adherence. Then, there is a reminder call at 6 months. Receives: Other: Nursing intervention programme |
| Usual care group | No intervention | The patient is followed up and regular visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with therapeutic adherence
The main outcome measured was therapeutic adherence 12 months after admission. The definition of adherence was a single measure taking into account 4 different methods (see below). Patients were considered adherent when the 4 criteria were present (called "global adherence").Measurement unit was: Number of patients with therapeutic adherence
- Morisky-Green Scale (MGLS): consists of a series of four questions with dichotomous answers (yes/no) that affect the patient's behaviour regarding compliance.
- Self-reported compliance communication: Haynes-Sackett method: involves asking the patient one question. If the answer is affirmative, is considered adherent.
- Records of dispensations in the pharmacy: Patients who withdrew all medications during the year were considered adherent.
- Attendance at scheduled appointments: It is recorded if the patient has missed any of the control visits by both the doctor and the nurse during the first year.
Measured: 12 months after admission
Secondary outcomes (3)
Rate of readmission,
Need for hospital readmission
Measured: During the 12 months after the admission
Rate of visits to the emergency room
Need for emergency visits at hospital
Measured: During the 12 months after the admission
Rate of mortality
Deaths of cardiac origin were those caused by myocardial infarction, sudden death or heart failure.
Measured: During the 12 months after the admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Apr 2016
- Primary completion28 Feb 2020
- Study completion28 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly assigned to a nursing intervention group or a usual care group (1:1). Nonprobabilistic, consecutive sampling was carried out with random assignment of the study groups.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Calvo, Hospital Universitari de Bellvitge
- Investigators
- Elena Calvo, RN, Principal investigator, Nurse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662762
- Sponsor's protocol ID
- PR034/16
- Status last verified
- Dec 2020
- First submitted
- 28 Nov 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calvo E, Izquierdo S, Castillo R, Cesar E, Domene G, Gomez AB, Guerrero C, Andreu-Periz L, Gomez-Hospital JA, Ariza-Sole A. Can an individualized adherence education program delivered by nurses improve therapeutic adherence in elderly people with acute myocardial infarction?: A randomized controlled study. Int J Nurs Stud. 2021 Aug;120:103975. doi: 10.1016/j.ijnurstu.2021.103975. Epub 2021 May 10.
PubMed 34102371
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nursing Intervention Program Significantly Improves Therapeutic Adherence in Elderly People With Acute Myocardial Infarction: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04662762
- Acronym / sponsor ID
- PR034/16
- Conditions
- Medication Adherence, Myocardial Infarction
- Keywords
- Elderly, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 10 Dec 2020 (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 objective of this study was to assess the impact of a nursing intervention on therapeutic adherence in elderly patients after acute myocardial infarction compared to a control group
Detailed description
A comprehensive geriatric assessment was performed during the first admission in all patients. Patients were randomly allocated to a nursing intervention group or a usual care group. In patients from the intervention group, a nursing intervention programme was performed 3 months after admission, based on education, support and patient monitoring to improve therapeutic adherence and a 6 month phone call. The main outcome measured was therapeutic adherence at 12 months, as defined by a combination of adherence measurement tools (Morisky-Green and Hayness-Sacket scales, attendance at visits and withdrawal of medication from the pharmacy). Therapeutic adherence was assessed by nurses blinded to the assignment group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomly assigned to a nursing intervention group or a usual care group (1:1). Nonprobabilistic, consecutive sampling was carried out with random assignment of the study groups.
| Arm | Type | Receives |
|---|---|---|
| nursing intervention group | Experimental | Other: Nursing intervention programmeAn educational interview by trained nurses was performed at three months in patients allocated to the intervention group. The visit was carried out at the hospital. Family and caregivers were also asked to attend this visit for instruction. For patients unable to move, the nursing team went to their home to perform the intervention, or it was conducted by phone. The duration of this interview was approximately 40 minutes and was focused on some measures and recommendations to improve or maintain adherence. Then, there is a reminder call at 6 months. |
| Usual care group | No intervention | –The patient is followed up and regular visits |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients with STEMI aged 75 years or older underwent primary percutaneous coronary intervention (PCI)
Key exclusion criteria (3 listed)
- Patients who refused to participate in the study
- Patients unable to perform geriatric assessment.
- Patients admitted to nursing homes or social health centres.
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 |
|---|---|---|
| Nursing intervention programmeeducational information | Other | nursing intervention group |
Primary outcome
Number of patients with therapeutic adherence
Time frame: 12 months after admission
The main outcome measured was therapeutic adherence 12 months after admission. The definition of adherence was a single measure taking into account 4 different methods (see below). Patients were considered adherent when the 4 criteria were present (called "global adherence").Measurement unit was: Number of patients with therapeutic adherence * Morisky-Green Scale (MGLS): consists of a series of four questions with dichotomous answers (yes/no) that affect the patient's behaviour regarding compliance. * Self-reported compliance communication: Haynes-Sackett method: involves asking the patient one question. If the answer is affirmative, is considered adherent. * Records of dispensations in the pharmacy: Patients who withdrew all medications during the year were considered adherent. * Attendance at scheduled appointments: It is recorded if the patient has missed any of the control visits by both the doctor and the nurse during the first year.
3 secondary outcomes
Rate of readmission,
Time frame: During the 12 months after the admission
Rate of visits to the emergency room
Time frame: During the 12 months after the admission
Rate of mortality
Time frame: During the 12 months after the admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Derived from this study: PubMed 34102371Calvo E, Izquierdo S, Castillo R, Cesar E, Domene G, Gomez AB, Guerrero C, Andreu-Periz L, Gomez-Hospital JA, Ariza-Sole A. Can an individualized adherence education program delivered by nurses improve therapeutic adherence in elderly people with acute myocardial infarction?: A randomized controlled study. Int J Nurs Stud. 2021 Aug;120:103975. doi: 10.1016/j.ijnurstu.2021.103975. Epub 2021 May 10.
- Individual participant dataSharing planned: No
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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.
Elena Calvo, RN principal investigator
Nurse
Questions about this trial
What is this clinical trial studying?
A study testing Nursing intervention programme in people with Medication Adherence and Myocardial Infarction, run by Hospital Universitari de Bellvitge.
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 1 inclusion and 3 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 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of patients with therapeutic adherence (time frame: 12 months after admission). 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 NCT04662762, 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 14 Dec 2020.