Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

To Achieve Blood Pressure Control With Retained Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682095
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Eva Drevenhorn, Lund University

Brief Summary:
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.

Condition or disease
Hypertension Patient Compliance

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Possibilities for Patients With Elevated Blood Pressure to Achieve Blood Pressure Control Without Affecting Quality of Life (the PEQ Study)
Actual Study Start Date : April 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Patients: achieved BP control
Patients who have achieved blood pressure control (≤140/90 mmHg)
Patients: not achieved BP control
Patients who have not achieved blood pressure control (>140/90 mmHg)
Individual interviews
Hypertensive patients who have considered changing lifestyle regarding one or more of the areas of tobacco, alcohol, diet, physical activity or stress.
Focus-group interviews
Hypertensive patients



Primary Outcome Measures :
  1. Self-care agency [ Time Frame: through study completion, an average of 6 months ]
    Exercise of Self Care Agency (ESCA) instrument

  2. Quality of life: SF-36 [ Time Frame: through study completion, an average of 6 months ]
    Short Form Health Survey, 36 items

  3. Individual interviews [ Time Frame: through study completion, an average of 3 months ]
    Semistructured interviews

  4. Focus-group interviews [ Time Frame: through study completion, an average of 1 year ]
    Discussions in focus-groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • diagnosed with hypertension since 9 months
  • being able to read and speak Swedish

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682095


Contacts
Layout table for location contacts
Contact: Eva Drevenhorn eva.drevenhorn@med.lu.se
Contact: Eva I Persson eva_i.persson@med.lu.se

Locations
Layout table for location information
Sweden
Department of Health Sciences Recruiting
Lund, Sweden, SE-221 00
Contact: Eva Drevenhorn       eva.drevenhorn@med.lu.se   
Contact: Eva I Persson       eva_i.persson@med.lu.se   
Sponsors and Collaborators
Eva Drevenhorn
Investigators
Layout table for investigator information
Principal Investigator: Lena-Karin Erlandsson Department of Health Sciences
Layout table for additonal information
Responsible Party: Eva Drevenhorn, Senior Lecturer, Lund University
ClinicalTrials.gov Identifier: NCT02682095    
Other Study ID Numbers: The PEQ-study
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Eva Drevenhorn, Lund University:
Hypertension
Blood Pressure Control
Adherence
Mixed Methods
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases