NCT01742923

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
532

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

1.7 years

First QC Date

December 4, 2012

Last Update Submit

November 17, 2015

Conditions

Hypertension

Keywords

hypertensionmedication adherencemotivational interviewing

Outcome Measures

Primary Outcomes (1)

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

    One year from inclusion

Secondary Outcomes (3)

  • 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

  • Reduction in systolic and diastolic blood pressure

    One year from inclusion

  • Composite endpoint (stroke, myocardial infarction or cardiovascular death)

    One year from inclusion

Study Arms (2)

Usual care

PLACEBO COMPARATOR

Usual care

Behavioral: Usual care

Complex tailored intervention

EXPERIMENTAL

The interventions consists of 3 elements: 1. Medication review with recommendations focused on antihypertensives and statins and adherence to guidelines and patient´s adherence to medications 2. Consultation with a pharmacist using motivational interviewing techniques 3. Follow-up telephone calls one month and six months after inclusion

Behavioral: Complex tailored intervention

Interventions

Complex tailored interventionBEHAVIORAL
Complex tailored intervention
Usual careBEHAVIORAL
Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 26302142RESULT

  • 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.

    PMID: 26088274RESULT

MeSH Terms

Conditions

HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, MSc (pharm), Odense University Hospital

Study Record Dates

First Submitted

December 4, 2012

First Posted

December 6, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

DK(1)