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A Nursing Intervention Program to Improve Therapeutic Adherence in Elderly People With Acute Myocardial Infarction

A Nursing Intervention Program Significantly Improves Therapeutic Adherence in Elderly People With Acute Myocardial Infarction: a Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04662762
Enrollment
160
Registered
2020-12-10
Start date
2016-04-01
Completion date
2020-05-28
Last updated
2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Adherence, Myocardial Infarction

Keywords

Elderly, Nursing

Brief 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

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.

Interventions

OTHERNursing intervention programme

educational information

Sponsors

Hospital Universitari de Bellvitge
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

The random assignment was made to the nursing intervention group and the usual care group, generating a list using the EPIDAT ® programme. This list contained the patient number and the assignment group. The randomization procedure was performed during hospitalization for AMI. The researcher did not know the assignment list, calling the research unit at the time of each patient inclusion by phone, when they were told to which group they would belong to once the first interview was over. The main outcome measured was therapeutic adherence 12 months after admission. This assessment was performed by trained nurses blinded to the group assignment.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with STEMI aged 75 years or older underwent primary percutaneous coronary intervention (PCI)

Exclusion criteria

* Patients who refused to participate in the study * Patients unable to perform geriatric assessment. * Patients admitted to nursing homes or social health centres.

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with therapeutic adherence12 months after admissionThe 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.

Secondary

MeasureTime frameDescription
Rate of readmission,During the 12 months after the admissionNeed for hospital readmission
Rate of visits to the emergency roomDuring the 12 months after the admissionNeed for emergency visits at hospital
Rate of mortalityDuring the 12 months after the admissionDeaths of cardiac origin were those caused by myocardial infarction, sudden death or heart failure.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026