Tailored Intervention to Improve Medication Adherence in Patients With Hypertension

Hypertension Clinical Trial

Official title:

Pharmacist Intervention Programme in Secondary Care to Improve Medication Adherence in Patients With Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742923
• Other study ID #: AKF-384
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: November 17, 2015
• Start date: December 2012
• Est. completion date: September 2014

Study information

• Verified date: November 2015
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

Patients with hypertension have an increased risk of stroke and myocardial infarction. However, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs frequently within this patient group. The purpose of this study is to investigate whether a complex tailored intervention in a hospital setting will lead to increased medication adherence and fewer cardiovascular events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age: 18 years or older

• Patients receiving ambulatory treatment for hypertension in a hospital setting

• The patient or a carer usually dispenses the patient's medications

• Patient lives in the Southern Region of Denmark

• Written consent

Exclusion Criteria:

• Lives in a care home or institution

• Receive dose dispensed medicine from a pharmacy

• Medicine is dispensed by a nurse in the patient's home

• Correctional mental health patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Complex tailored intervention

• Usual care

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense C

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Hedegaard U, Hallas J, Ravn-Nielsen LV, Kjeldsen LJ. Process- and patient-reported outcomes of a multifaceted medication adherence intervention for hypertensive patients in secondary care. Res Social Adm Pharm. 2016 Mar-Apr;12(2):302-18. doi: 10.1016/j.sa — View Citation

Hedegaard U, Kjeldsen LJ, Pottegård A, Henriksen JE, Lambrechtsen J, Hangaard J, Hallas J. Improving Medication Adherence in Patients with Hypertension: A Randomized Trial. Am J Med. 2015 Dec;128(12):1351-61. doi: 10.1016/j.amjmed.2015.08.011. Epub 2015 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins		One year from inclusion	No
Secondary	Non-persistence with antihypertensives and statins measured by percent of patients that are not supplied with medications for more than three continuous months		One year from inclusion	No
Secondary	Reduction in systolic and diastolic blood pressure		One year from inclusion	No
Secondary	Composite endpoint (stroke, myocardial infarction or cardiovascular death)		One year from inclusion	No