- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03111836
Effectiveness of User and Expert Driven Internet-based Lifestyle Interventions on Hypertension Control
7. april 2017 opdateret af: sam liu, University of Toronto
Hypertension is a leading risk factor for cardiovascular disease and mortality.
Lifestyle counseling is recommended as a first line therapy for reducing blood pressure (BP) and risk for cardiovascular events.
Recent studies suggest that e-based lifestyle interventions are effective in evoking therapeutic change in BP1.
However, BP response and adherence to exercise and diet behavior varies significantly after e-based interventions due to variations in treatment methodologies.
Consensus is not yet established for a standardized e-counseling protocol for hypertension.
As noted in our systematic review, the two dominant models of e-counseling procedures are expert-driven (protocol driven, prescriptive) and user-driven (self-guided, collaborative).
Expert-driven programs prescribe specific changes for lifestyle behavior which are intended to facilitate compliance to behavioral change.
In contrast, the user-driven method actively involves the subject in goal-setting and/or the selection of the intervention used to reach the behavioral goal.
One conclusion from the systematic review is that these models are used indiscriminately in e-counseling programs.
There is currently inadequate data to determine the efficacy of programs that are expert-driven vs. user-driven in reducing BP while modifying lifestyle behaviour.
It is possible that a combination of expert-driven and user-driven features for lifestyle e-counseling is most effective.
However, before these two approaches can be combined, it is essential to establish the strengths and limitations of each model.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study will use a 3-parallel group, randomized controlled design: 3 (Groups: Control, expert-driven, and user-driven e-Counselling) by 2 (Assessments: baseline, 4-month).
Controls will receive general e-information on BP management.
The expert-driven e-Counselling group will provide a prescribed exercise and a diet plan.
The user-driven e-Counselling group will a program that enables the patient to choose areas of focus.
All subjects will be sent 16 e-messages on a weekly schedule.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
129
Fase
- Ikke anvendelig
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
35 år til 74 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Unchanged prescription for anti-hypertensive medication at least 2 months before enrollment.
- Participants prescribed antihypertensive medication were also required to have SBP ≥130 mmHg and/or DBP ≥85 mmHg, in order to prevent "floor effects".
Exclusion criteria included:
- Diagnosis of kidney disease, major psychiatric illness (e.g. psychosis), alcohol or drug dependence in the previous year, pregnancy and sleep apnea. There was no racial or gender bias in the selection of participants.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Sham-komparator: Control group
The Control group received limited to general information on blood pressure management
|
Received general information about blood pressure control.
All subjects will be sent 16 e-messages on a weekly schedule.
|
Aktiv komparator: Expert-driven group
The intervention will consisted of pre-determined exercise and dietary goals (e.g. increase daily steps by 1000 steps, consuming 2-3 servings of fruit and vegetables per day).
|
The user-driven e-Counselling group will receive a lifestyle program where the user are able to choose areas of focus.
All subjects will be sent 16 e-messages on a weekly schedule.
|
Aktiv komparator: User-driven group
The User-driven group received an intervention that enabled participants to select their areas of lifestyle change using text and video web links embedded in the email.
The trans-theoretical model was used to inform the design of the User-driven program.
|
The user-driven e-Counselling group will receive a lifestyle program where the user are able to choose areas of focus.
All subjects will be sent 16 e-messages on a weekly schedule.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Systolic Blood Pressure
Tidsramme: Change from Baseline Systolic Blood Pressure at 4 months
|
Change from Baseline Systolic Blood Pressure at 4 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Diastolic Blood Pressure
Tidsramme: Change from Baseline Diastolic Blood Pressure at 4 months
|
Change from Baseline Diastolic Blood Pressure at 4 months
|
|
Blood Lipids (HDL, LDL, Cholesterol)
Tidsramme: Change from Baseline Blood Lipids (HDL, LDL, Cholesterol) at 4 months
|
Change from Baseline Blood Lipids (HDL, LDL, Cholesterol) at 4 months
|
|
Fruit and Vegetables
Tidsramme: Change from Baseline Daily servings of Fruit and Vegetables at 4 months
|
Diet History Questionaire
|
Change from Baseline Daily servings of Fruit and Vegetables at 4 months
|
Daily Steps
Tidsramme: Change from Baseline Daily Steps at 4 months
|
Pedometer
|
Change from Baseline Daily Steps at 4 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. juni 2012
Primær færdiggørelse (Faktiske)
1. juli 2014
Studieafslutning (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først indsendt
4. april 2017
Først indsendt, der opfyldte QC-kriterier
7. april 2017
Først opslået (Faktiske)
13. april 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. april 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. april 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UT01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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