- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05145634
The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant
2021년 11월 22일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
150
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
|
간섭 없음: Control group
Patients in the control group only received brochure and medication cards.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The change of "medication knowledge of anticoagulants"
기간: 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"
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The change of "medication satisfaction of anticoagulants"
기간: 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"
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Yu-Hsia Tsai, Chang Gung University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2014년 12월 1일
기본 완료 (실제)
2018년 2월 28일
연구 완료 (실제)
2018년 2월 28일
연구 등록 날짜
최초 제출
2021년 7월 23일
QC 기준을 충족하는 최초 제출
2021년 11월 22일
처음 게시됨 (실제)
2021년 12월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 12월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 11월 22일
마지막으로 확인됨
2021년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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