- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00242658
Computerized Health Education to Promote Physical Activity
7. november 2012 opdateret af: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
Computerized Physical Activity Promotion in Primary Care
This study will test the efficacy of providing primary care physicians and their patients with computer-tailored information, based on patients' responses to survey questions.
The health education messages are designed to encourage patients to become physically active and to encourage physicians to counsel their patients about exercise.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The main objective of this study is to determine, via a 6-month randomized controlled study, the efficacy of providing tailored physical activity computer reports to patients and physicians.
The primary outcome is minutes of physical activity measured by the 7-Day Physical Activity Recall interview at 6 months.
The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months.
Based on their responses, participants received four feedback reports at each time point.
The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription.
The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
394
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Jefferson Family Medicine Associates
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Jefferson Medical College, Department of Health Policy
-
-
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
21 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Ability to speak and read English
- Current patient of a physician participating in this study (if selecting a new physician, may deliberately select one that is involved in the study, in order to participate)
- Ability to complete all written surveys
- Accessible for follow-up telephone surveys
- Ability to undergo exercise testing
Exclusion Criteria:
- Currently participating in another research study
- Planning to move out of the Philadelphia area
- Unable to walk without pain
- Pregnant or planning to become pregnant in the year following study entry
- Excessive drinking
- Coronary heart disease
- Congestive heart failure
- Peripheral vascular disease
- Cerebrovascular disease
- Chronic obstructive pulmonary disease
- Arrhythmia
- Recurrent seizures
- Dizziness
- Balance problems
- Psychoses
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Tailored Physical Activity Intervention Group
Four feedback reports aimed to increase physical activity.
|
Tailored physical activity computer reports will be provided to patients and physicians.
Andre navne:
|
|
Ingen indgriben: No Tailored Physical Activity Intervention Group
General reports on preventive screening based on responses to preventive screening questions.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
7-Day Physical Activity Recall (7-Day PAR)
Tidsramme: 6 months
|
Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days.
It was administered to study participants at baseline and 6 months.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Behavioral Processes of Change Between Baseline and 6 Months
Tidsramme: Baseline and 6 months
|
Behavioral processes were assessed by asking participants to rate their responses to 24 statements on a Likert scale (1 = never to 5 = repeatedly) to statements such as, "I tell myself I am able to be physically active if I want to.
To create the overall measure, individual items are averaged.
Higher numbers represent greater use of behavioral processes of change, so that the overall scale retains a maximum of 5.0 and minimum value of 1.0.
The scale values are not numerical, they represent scores on the scale, where 5=repeatedly and 1=never.
|
Baseline and 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Christopher N. Sciamanna, MD, MPH, Jefferson Medical College, Department of Health Policy
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
1. maj 2005
Primær færdiggørelse (Faktiske)
1. december 2007
Studieafslutning (Faktiske)
1. marts 2008
Datoer for studieregistrering
Først indsendt
19. oktober 2005
Først indsendt, der opfyldte QC-kriterier
19. oktober 2005
Først opslået (Skøn)
20. oktober 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. november 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. november 2012
Sidst verificeret
1. november 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 269
- 7R01HL067005-03 (U.S. NIH-bevilling/kontrakt)
- 02F.214 CHIP
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 .