- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02682095
To Achieve Blood Pressure Control With Retained Quality of Life
5. marts 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
12
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Lund, Sverige, SE-221 00
- Department of Health Sciences
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria:
- diagnosed with hypertension since 9 months
- being able to read and speak Swedish
Exclusion Criteria:
-
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-care agency
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Lena-Karin Erlandsson, Department of Health Sciences
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2016
Primær færdiggørelse (Faktiske)
31. maj 2019
Studieafslutning (Faktiske)
31. maj 2019
Datoer for studieregistrering
Først indsendt
8. februar 2016
Først indsendt, der opfyldte QC-kriterier
10. februar 2016
Først opslået (Skøn)
15. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- The PEQ-study
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .