Back to resultsA Nursing Intervention Program to Improve Therapeutic Adherence in Elderly People With Acute Myocardial Infarction
Primary Purpose
Medication Adherence, Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nursing intervention programme
Sponsored by
About this trial
This is an interventional prevention trial for Medication Adherence focused on measuring Elderly, Nursing
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
nursing intervention group
Usual care group
Arm Description
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.
The patient is followed up and regular visits
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of readmission,
Need for hospital readmission
Rate of visits to the emergency room
Need for emergency visits at hospital
Rate of mortality
Deaths of cardiac origin were those caused by myocardial infarction, sudden death or heart failure.
Full Information
NCT ID
NCT04662762
First Posted
November 28, 2020
Last Updated
December 10, 2020
Sponsor
Hospital Universitari de Bellvitge
1. Study Identification
Unique Protocol Identification Number
NCT04662762
Brief Title
A Nursing Intervention Program to Improve Therapeutic Adherence in Elderly People With Acute Myocardial Infarction
Official Title
A Nursing Intervention Program Significantly Improves Therapeutic Adherence in Elderly People With Acute Myocardial Infarction: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
May 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Myocardial Infarction
Keywords
Elderly, Nursing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nursing intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
The patient is followed up and regular visits
Intervention Type
Other
Intervention Name(s)
Nursing intervention programme
Intervention Description
educational information
Primary Outcome Measure Information:
Title
Number of patients with therapeutic adherence
Description
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.
Time Frame
12 months after admission
Secondary Outcome Measure Information:
Title
Rate of readmission,
Description
Need for hospital readmission
Time Frame
During the 12 months after the admission
Title
Rate of visits to the emergency room
Description
Need for emergency visits at hospital
Time Frame
During the 12 months after the admission
Title
Rate of mortality
Description
Deaths of cardiac origin were those caused by myocardial infarction, sudden death or heart failure.
Time Frame
During the 12 months after the admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Calvo, RN
Organizational Affiliation
Nurse
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34102371
Citation
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.
Results Reference
derived
Learn more about this trial
A Nursing Intervention Program to Improve Therapeutic Adherence in Elderly People With Acute Myocardial Infarction
We'll reach out to this number within 24 hrs