HypertensionNCT02682095
To Achieve Blood Pressure Control With Retained Quality of Life
An observational study of Hypertension and Patient Compliance, run by Eva Drevenhorn at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension, Patient Compliance
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2016to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- diagnosed with hypertension since 9 months
- being able to read and speak Swedish
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Patient Compliance
- Keywords
- Hypertension, Blood Pressure Control, Adherence, Mixed Methods
- Medical subject headings
- Hypertension, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care agency
Exercise of Self Care Agency (ESCA) instrument
Measured: through study completion, an average of 6 months
Quality of life: SF-36
Short Form Health Survey, 36 items
Measured: through study completion, an average of 6 months
Individual interviews
Semistructured interviews
Measured: through study completion, an average of 3 months
Focus-group interviews
Discussions in focus-groups
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startApr 2016
- Primary completion31 May 2019
- Study completion31 May 2019
Why it stopped: Only part three, the individual interviews, has been carried out. We have not been able to get funding to complete the rest of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eva Drevenhorn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eva Drevenhorn, Lund University
- Investigators
- Lena-Karin Erlandsson, Principal investigator, Department of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682095
- Sponsor's protocol ID
- The PEQ-study
- Status last verified
- Mar 2021
- First submitted
- 8 Feb 2016
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possibilities for Patients With Elevated Blood Pressure to Achieve Blood Pressure Control Without Affecting Quality of Life (the PEQ Study)
- ClinicalTrials.gov ID
- NCT02682095
- Acronym / sponsor ID
- The PEQ-study
- Conditions
- Hypertension, Patient Compliance
- Keywords
- Hypertension, Blood Pressure Control, Adherence, Mixed Methods
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Only part three, the individual interviews, has been carried out. We have not been able to get funding to complete the rest of the study.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eva DrevenhornUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- diagnosed with hypertension since 9 months
- being able to read and speak Swedish
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-care agency
Time frame: through study completion, an average of 6 months
Exercise of Self Care Agency (ESCA) instrument
Quality of life: SF-36
Time frame: through study completion, an average of 6 months
Short Form Health Survey, 36 items
Individual interviews
Time frame: through study completion, an average of 3 months
Semistructured interviews
Focus-group interviews
Time frame: through study completion, an average of 1 year
Discussions in focus-groups
Results and safety
The study was stopped early (reason given: Only part three, the individual interviews, has been carried out. We have not been able to get funding to complete the rest of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena-Karin Erlandsson principal investigator
Department of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Patient Compliance, run by Eva Drevenhorn at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Only part three, the individual interviews, has been carried out. We have not been able to get funding to complete the rest of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-care agency (time frame: through study completion, an average of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.