The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant
22 november 2021 uppdaterad av: Chang Gung Memorial Hospital
The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant: A Randomized Control Trial
This study examined patients on taking oral anticoagulants (OACs) are often prescribed for Atrial fibrillation (AFib) to determine the effectiveness of a multiple interactive health education program, which was developed based on the health belief model (HBM) and incorporated information technologies.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
A randomized controlled study was conducted on the cardiology outpatients.
The patients were recruited through purposive sampling.
The participants had been diagnosed with AFib and were receiving OACs.
The participants were divided according to the blocks of clinic hours and assigned randomly to the experimental group or control group.
The control variables involved demographic characteristics and medical history.
The dependent variables and corresponding research instruments were medication knowledge and health beliefs, medication satisfaction and quality of life (QoL).
Other than the medication knowledge questionnaire, which was assessed monthly, all the measurement instruments were applied twice: first in a pretest, and again in a posttest administered at the third month.
The interventions administered to the experimental group were one-on-one instruction and HBM-driven strategies, health information technology system, monthly telephone follow-ups, and providing medication cards.
The participants in the control group only received brochure and medication cards.
Studietyp
Interventionell
Inskrivning (Faktisk)
150
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- diagnosis of Atrial Fibration by a physician and taking oral anticoagulant as treatment
- 20years old or older
- clear consciousness for communication
- willingness to participate in research.
Exclusion Criteria:
- can not communicate clearly
- without willingness to participate in research
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Educational group
The interventions administered to the experimental group were one-on-one instruction and Health Brief Model (HBM)-driven strategies, health information technology system, monthly telephone follow-ups, and providing medication cards.
|
The interventions administered to the experimental group were one-on-one instruction and Health Belief Model (HBM)-driven strategies, health information technology system, monthly telephone follow-ups, and providing medication cards.
Patient education related oral anticoagulant: each subject in the experimental group was taught individually according to investigators' App in the outpatient department (OPD) by researchers.
Every months, participants received a follow-up phone call to clarify any questions related to the knowledge of anticoagulants.
The contents of the teaching material consisted of: the purpose of taking anticoagulant, side effects, adjustments to daily diet, and precautions (i.e.how to take medication safely, interaction between foods and medicine, prevention and checking of signs and symptoms of bleeding).
The control group received the brochure and medical card after pretest and routine care in the OPD.
All participants completed posttest at 3-month follow-up.
|
|
Inget ingripande: Control group
Patients in the control group only received brochure and medication cards.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The change of "medication knowledge of anticoagulants"
Tidsram: medication knowledge of anticoagulants was assessed at baseline, change from baseline medication knowledge of anticoagulants at 2 months, and change from baseline medication knowledge of anticoagulants at 3 months
|
There were 11 questions related to knowledge of anticoagulants designed by investigators' research team.
The range of scores was 0-22.
The higher the score, the better the participants' knowledge of anticoagulants was.
|
medication knowledge of anticoagulants was assessed at baseline, change from baseline medication knowledge of anticoagulants at 2 months, and change from baseline medication knowledge of anticoagulants at 3 months
|
|
The change of "health beliefs of anticoagulants"
Tidsram: health beliefs of anticoagulants were assessed at baseline, and change from baseline health beliefs of anticoagulants at 3 months
|
There were 22 questions related to health beliefs of anticoagulants designed by investigators' research team.
The range of scores was 0-88.
The higher the score, the better the participants' health beliefs was.
|
health beliefs of anticoagulants were assessed at baseline, and change from baseline health beliefs of anticoagulants at 3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The change of "medication satisfaction of anticoagulants"
Tidsram: medication satisfaction of anticoagulants was assessed at baseline, and change from baseline medication satisfaction of anticoagulants at 3 months
|
There were 26 questions related to medication satisfaction of anticoagulants (Duke Anticoagulation Satisfaction Scale, DASS).
The range of scores was 1-182.
The lower the score, the better the participants' medication satisfaction was.
|
medication satisfaction of anticoagulants was assessed at baseline, and change from baseline medication satisfaction of anticoagulants at 3 months
|
|
The change of "quality of life for patients taking anticoagulants"
Tidsram: quality of life for patients taking anticoagulants was assessed at baseline, and change from baseline quality of life for patients taking anticoagulants at 3 months
|
There were 12 questions related to quality of life for patients taking anticoagulants (Short Form-12, SF-12).
The range of scores was 0-100 transferred in each question.
The higher the score, the better the participants' quality of life was.
|
quality of life for patients taking anticoagulants was assessed at baseline, and change from baseline quality of life for patients taking anticoagulants at 3 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Yu-Hsia Tsai, Chang Gung University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2014
Primärt slutförande (Faktisk)
28 februari 2018
Avslutad studie (Faktisk)
28 februari 2018
Studieregistreringsdatum
Först inskickad
23 juli 2021
Först inskickad som uppfyllde QC-kriterierna
22 november 2021
Första postat (Faktisk)
6 december 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 december 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 november 2021
Senast verifierad
1 juli 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 103-5623B
Läkemedels- och apparatinformation, studiedokument
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Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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