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Tailored Intervention to Improve Medication Adherence in Patients With Hypertension

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Complex tailored intervention
Usual care
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring hypertension, medication adherence, motivational interviewing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Usual care

Complex tailored intervention

Arm Description

Usual care

The interventions consists of 3 elements: Medication review with recommendations focused on antihypertensives and statins and adherence to guidelines and patient´s adherence to medications Consultation with a pharmacist using motivational interviewing techniques Follow-up telephone calls one month and six months after inclusion

Outcomes

Primary Outcome Measures

Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins

Secondary Outcome Measures

Non-persistence with antihypertensives and statins measured by percent of patients that are not supplied with medications for more than three continuous months
Reduction in systolic and diastolic blood pressure
Composite endpoint (stroke, myocardial infarction or cardiovascular death)

Full Information

First Posted
December 4, 2012
Last Updated
November 17, 2015
Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01742923
Brief Title
Tailored Intervention to Improve Medication Adherence in Patients With Hypertension
Official Title
Pharmacist Intervention Programme in Secondary Care to Improve Medication Adherence in Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, medication adherence, motivational interviewing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
532 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Placebo Comparator
Arm Description
Usual care
Arm Title
Complex tailored intervention
Arm Type
Experimental
Arm Description
The interventions consists of 3 elements: Medication review with recommendations focused on antihypertensives and statins and adherence to guidelines and patient´s adherence to medications Consultation with a pharmacist using motivational interviewing techniques Follow-up telephone calls one month and six months after inclusion
Intervention Type
Behavioral
Intervention Name(s)
Complex tailored intervention
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins
Time Frame
One year from inclusion
Secondary Outcome Measure Information:
Title
Non-persistence with antihypertensives and statins measured by percent of patients that are not supplied with medications for more than three continuous months
Time Frame
One year from inclusion
Title
Reduction in systolic and diastolic blood pressure
Time Frame
One year from inclusion
Title
Composite endpoint (stroke, myocardial infarction or cardiovascular death)
Time Frame
One year from inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26302142
Citation
Hedegaard U, Kjeldsen LJ, Pottegard 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 Aug 21.
Results Reference
result
PubMed Identifier
26088274
Citation
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.sapharm.2015.05.006. Epub 2015 May 18.
Results Reference
result

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Tailored Intervention to Improve Medication Adherence in Patients With Hypertension

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