- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02682095
To Achieve Blood Pressure Control With Retained Quality of Life
March 5, 2021 updated by: Eva Drevenhorn
Possibilities for Patients With Elevated Blood Pressure to Achieve Blood Pressure Control Without Affecting Quality of Life (the PEQ Study)
The purpose of the study is to get an understanding about what problems patients with hypertension are facing, how they manage these challenges, how they feel and what requirements they believe are important to have in their treatment.
These factors will later act as a foundation and incentive for designing an intervention that may result in more patients achieving blood pressure control with maintained quality of life.
Study Overview
Status
Terminated
Conditions
Detailed Description
This is a Swedish observational mixed-methods study to get an understanding about what problems patients with hypertension are facing.
The information will act as a foundation for designing an intervention/interventions that may result in more patients achieving blood pressure control with maintained quality of life.
Patients, who have well/not well controlled blood pressure, are to fill in questionnaires about their view on ability to perform self-care and their perceived quality of life.
Individual interviews will also be made about for what reasons they do or do not change lifestyle as well as take their drugs to treat their hypertension.
In focus group interviews the patients are to be asked about what they want and expect in the encounter with health care personnel, what other things outside the health care area would be helpful for the patient and how age, gender, cultural and psychosocial aspects affect the ability to achieve blood pressure control.
The developed future interventions will be evaluated in clinical practice.
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lund, Sweden, SE-221 00
- Department of Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
To preserve that the population is representative for an area in southern Sweden, patients are to be included consequtively through stratified sampling regarding age, gender and treatment at health centre or medical clinic at a hospital as well as geographically.
Description
Inclusion Criteria:
- diagnosed with hypertension since 9 months
- being able to read and speak Swedish
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients: achieved BP control
Patients who have achieved blood pressure control (≤140/90 mmHg)
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Patients: not achieved BP control
Patients who have not achieved blood pressure control (>140/90 mmHg)
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Individual interviews
Hypertensive patients who have considered changing lifestyle regarding one or more of the areas of tobacco, alcohol, diet, physical activity or stress.
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Focus-group interviews
Hypertensive patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-care agency
Time Frame: through study completion, an average of 6 months
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Exercise of Self Care Agency (ESCA) instrument
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through study completion, an average of 6 months
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Quality of life: SF-36
Time Frame: through study completion, an average of 6 months
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Short Form Health Survey, 36 items
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through study completion, an average of 6 months
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Individual interviews
Time Frame: through study completion, an average of 3 months
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Semistructured interviews
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through study completion, an average of 3 months
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Focus-group interviews
Time Frame: through study completion, an average of 1 year
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Discussions in focus-groups
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through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lena-Karin Erlandsson, Department of Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
May 31, 2019
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
February 8, 2016
First Submitted That Met QC Criteria
February 10, 2016
First Posted (Estimate)
February 15, 2016
Study Record Updates
Last Update Posted (Actual)
March 9, 2021
Last Update Submitted That Met QC Criteria
March 5, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- The PEQ-study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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