Tailored Intervention to Improve Medication Adherence in Patients With Hypertension

NCT ID: NCT01742923

Last Updated: 2015-11-18

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

532 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual care

Usual care

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Complex tailored intervention

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

Group Type EXPERIMENTAL

Complex tailored intervention

Intervention Type BEHAVIORAL

Interventions

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Complex tailored intervention

Intervention Type BEHAVIORAL

Usual care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ulla Hedegaard

PhD student, MSc (pharm), Odense University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Odense University Hospital

Odense C, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 26302142 (View on PubMed)

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.

Reference Type RESULT
PMID: 26088274 (View on PubMed)

Other Identifiers

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AKF-384

Identifier Type: -

Identifier Source: org_study_id