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

NCT ID: NCT04662762

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2020-05-28

Brief Summary

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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

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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

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Medication Adherence Myocardial Infarction

Keywords

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Elderly Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

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nursing intervention group

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.

Group Type EXPERIMENTAL

Nursing intervention programme

Intervention Type OTHER

educational information

Usual care group

The patient is followed up and regular visits

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nursing intervention programme

educational information

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari de Bellvitge

OTHER

Sponsor Role lead

Responsible Party

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Elena Calvo

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elena Calvo, RN

Role: PRINCIPAL_INVESTIGATOR

Nurse

References

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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.

Reference Type DERIVED
PMID: 34102371 (View on PubMed)

Other Identifiers

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PR034/16

Identifier Type: -

Identifier Source: org_study_id