- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02502292
Innovative Policies for Healthy Aging (IROHLA)
Sustainable Health Systems Through Health Literacy for Healthy Aging
연구 개요
상세 설명
In this study, the researchers evaluate an intervention aiming to increase participation and communication of older adults during primary care consultations with their General Practitioner (GP). The researchers are particularly interested in a Photo novel tool with this aim. Photo novels are picture stories, which have the advantage of using a familiar narrative format, thereby possibly increasing comprehension, personal involvement and motivation and self-efficacy to perform the relevant behaviors by offering role models (story characters that are similar to older adults themselves). The patient perspective on doctor-patient communication is underrepresented in most research. This study aims to incorporate the patient perspective in different ways: in addressing their needs and barriers during focus group discussions, in collecting their communication strategies and solutions to these barriers in the role play exercise, in involving them in developing the photo novel, and in studying their responses to the photo novel in the evaluation study the researchers describe in this research protocol.
Aim of the intervention (the Photo novel) is to:
- increase older adults' awareness of their needs and barriers in conversations with their GP;
- improve older adults' access to information by enabling them to ask different and more questions to their GP;
- increase older adults' problem solving abilities during conversations with their GP to ensure better self-management of health issues.
- find out which format is most efficacious
This could include being honest about limited understanding, asking for more information to enable or improve shared decision making during consultation or to enable or improve self-management after consultation. This could also include filtering information and enabling patients to determine relevance of information. Furthermore, this could include strategies to translate advice into concrete actions, e.g. transforming 'knowing that' into 'knowing how' (I know / understand that I have to use less salt but… How to… decrease salt-intake in daily life?) In our photo novel, the researchers will provide older adults with 'template communicative behaviors' embedded in a picture story they can use before and during primary care consultations with their GP. Relevant communicative behaviors will include 'asking questions', 'expressing lack of or misunderstanding', 'expressing uncertainty', 'expressing preferences and needs' and other relevant communicative behaviors that will be identified during the focus group discussions with older adults and their informal care givers. These relevant communicative behaviors are embedded within different relevant domains, based on communication theory / literature and on the output of the focus group discussions. The seven scenarios are linked to the endpoints of medical communication framework developed by Haes and Bensing.
The researchers propose to evaluate the effectiveness of the photo novel using an Experimental Design, including both quantitative and qualitative measurements. This combination of measurements will provide us with insight with regard to three important Research Questions:
- To what extent is a photo novel an effective tool / intervention to empower older adults in their conversations with their GP compared to a traditional brochure containing tips on GP-patient communication?
- Which elements or domains included in the photo novel are effective and why?
- Which narrative / theoretical mechanisms account for the effectiveness of the photo novel ?
The researchers will recruit older adult participants (>50 years), who live in areas indicative of limited or marginal health literacy. The researchers perform the following procedure for recruitment. The researchers recommend to build relationships with GP practices, healthcare organizations and community organizations and ask them for their cooperation during a pre-established period of time. The researchers pay careful attention to this part of our study, e.g. carefully design recruitment wording: 'We are conducting a study to improve the relationship/ conversations with your GP, as a way to make sure the health care you receive is improved. We invite you to participate in this study. Would you like to participate?' Participants will be asked to come to a neutral setting, for example within the University, or will be visited in a community building, to take part in our study. Based on their consent to participate, a schedule is developed with eligible patients. Participants will be randomized to one of the two conditions and will be presented with the photo novel or traditional brochure either presented as a hard copy brochure or as pdf on a tablet computer (2x2 factorial design) and the accompanying questionnaire. The researchers aim for participants of different ages.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Bremen, 독일, 28759
- Jacobs University Bremen gGmbH
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Areas indicative of limited or marginal health literacy
- Carry out in a neutral setting
Exclusion Criteria:
- Eye-sight or hearing disabled people. This is because this study requires participants have the ability to read and watch and listen to videos.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention: Fotonovela
The Photo Novel Intervention is presented to users of four different facilities (sports clubs, senior homes) who are older than 50 years.
The researchers welcome scheduled eligible participants, introduce the study and ask them for their consent.
Afterwards, the participants are asked to fill in the questionnaire.
Then, participants are randomized to one of the four groups and are presented with the photo novel or traditional brochure either as a hard copy brochure or as pdf on a tablet computer (2x2 group design).
They are instructed to read the material in their own pace and answer the accompanying questions after each story / tip.and the accompanying questionnaire.
|
Comparing fotonovela brochure to traditional brochure, as a template communicative behaviors embedded in a picture story where the older people could use before and during primary care consultations with their GP. Relevant communicative behaviors will include 'asking questions', 'expressing lack of or misunderstanding', 'expressing uncertainty', 'expressing preferences and needs' and other relevant communicative behaviors which are based on communication theory / literature and on the output of the focus group discussions. The researchers will randomly assigned the participants into four groups as described earlier. Mainly to identify the outcomes of the comparison between fotonovela and traditional brochure in both traditional hard-copy and in tablet. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Health literacy will be assessed by questions in a questionnaire
기간: 30 minutes
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30 minutes
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sonia Lippke, Prof.Dr., Jacobs University Bremen
- 수석 연구원: Ruth Koops van 't Jagt, Msc., Reichuniversität Groningen/UMCG
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- FP7/2007-2013
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. .
건강 행동에 대한 임상 시험
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University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH) 그리고 다른 협력자들모집하지 않고 적극적으로
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University of Dublin, Trinity College알려지지 않은Brain Health 은퇴 엘리트 선수
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University아직 모집하지 않음Focus Health 임산부
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University College London HospitalsUniversity College, London완전한
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Istanbul University - Cerrahpasa (IUC)모병
Fotonovela에 대한 임상 시험
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The University of Texas at ArlingtonColumbia University; National Institute on Minority Health and Health Disparities (NIMHD); University of Texas Southwestern Medical Center완전한