- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04352179
Evaluation of Patient Education Simulations to Promote Health and Wellness
Evaluation of Patient Education Simulations to Promote Health and Wellness in Patients With Chronic Disease
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The overarching goal of the pilot study is to assess the acceptability and potential efficacy of the participant education simulation on changes in participants with chronic diseases' lifestyle behaviors as well as motivation and self-efficacy to change.
The primary objective is to examine the acceptability (satisfaction, usability) of using virtual simulations to deliver participant education and counseling for adopting healthy lifestyle behaviors among a sample of four healthcare providers and 60 participants with chronic disease. The secondary objectives include examining changes in lifestyle behaviors (e.g., healthy eating, physical activity) one-month following the use of the participant education simulations in a sample of 60 participants with chronic disease (e.g. cancer, cardiovascular disease, diabetes, stroke, arthritis) and to explore the potential mediators (e.g. motivation and self-efficacy) of the simulation effects on the changes in participants' lifestyle behaviors.
Participants will communicate with a virtual human, Linda, by selecting from a dynamic menu of dialogue options. Once the learner chooses a dialogue option, they see the virtual human respond by providing personalized feedback and give users an opportunity to revise their choice. In this study, the simulations will be a bundle of four topic-based conversations with Linda, which include fitness and nutrition, smoking cessation, alcohol use, distress and anxiety.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
New York
-
New York, New York, Spojené státy, 10016
- NYU Langone Health
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age 18 years or older;
- Have a diagnosis of a chronic disease (e.g., osteoarthritis, coronary artery disease, chronic obstructive pulmonary disease, asthma, diabetes, hypertension, stroke, and congestive heart failure) as indicated by self-report or review of the electronic medical record; and
- Receiving care within the NYU Langone Health Network (e.g., Faculty Group Practices and ambulatory care centers, NYU Winthrop Surgical Associates)
Exclusion Criteria:
- Are unable to give informed consent
- Refuse to participate
- Any active terminal illness, mental incompetence, or uncontrolled psychiatric illness. These exclusions were based on the premise that the presence of any of these conditions would dominate the subject's perception of lifestyle management of their chronic disease.
- Unable to speak and read in English. Patients that are unable to speak and read in English will be excluded from the proposed project because the simulations are being developed in English only. Once we demonstrate the initial efficacy of this tool, future simulations will be developed in languages other than English. Despite the language restrictions, no exclusion will be made based on patient racial/ethnic origin.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Virtual Education Simulation
All participants will have access to the virtual education simulations.
|
The simulations will be developed using Kognito's proprietary Conversation Platform. In this pilot study, the simulations will be a bundle of four topic-based conversations with Linda, a virtual peer with a chronic disease. The four wellness topics are:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Number of participants who were unsatisfied and satisfied by use of virtual simulations for education delivery and counseling
Časové okno: Immediately post-simulation (Day 0)
|
A Usability Questionnaire will be used for participants to rate how much they agree or disagree with 14 questions as they relate to the participants' conversation with the virtual coach.
Choices for each question range include: strongly disagree, somewhat disagree, somewhat agree, and strongly agree.
No numerical scale is used.
|
Immediately post-simulation (Day 0)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in score of Alcohol Abstinence Self-Efficacy (AASE) Scale
Časové okno: Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
The AASE Scale consists of 40 situations that lead some people to drink.
Participants mark answers which reflect how tempted they may be to drink in each situation at the present time.
The answers choices range from 0 (not at all) to 4 (extremely).
The range of score is 0-160.
The higher the score, the higher the temptation to drink.
|
Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
Score of Short Portable Mental Status Questionnaire (SPMSQ)
Časové okno: Baseline (Day 0)
|
10 questions will be asked to the participants.
All responses must be given without reference to calendar, newspaper, birth certificate, or other aid to memory.
The total number of errors based on the answers to the 10 questions will be recorded as the score.
The lower the score, the better.
0-2 errors = Intact Intellectual Functioning, 3-4 errors = Mild Intellectual Impairment, 5-7 errors = Moderate Intellectual Impairment, 8-10 errors = Severe Intellectual Impairment.
|
Baseline (Day 0)
|
Change in score of Smoking Abstinence Self-Efficacy Questionnaire (SASEQ)
Časové okno: Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
The SASEQ consists of 6 situations that lead some people to smoke.
Participants mark answers which reflect how confident they feel that they will not smoke in each situation.
The answer choices range from 0 (certainly) to 4 (certainly not).
The range of score is 0-24.
|
Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
Score of Patient Health Questionnaire-8 (PHQ-8)
Časové okno: Baseline (Day 0)
|
PHQ-8 consists of 8 problem situations.
The questionnaire asks the participants how often they have been bothered by each problem over the last 2 weeks.
The total score ranges from 0-12, with categories of psychological distress being: none (0-2), mild (3-5), moderate (6-8), and severe (9-12).
Therefore, the lower the score, the better.
|
Baseline (Day 0)
|
Change in amount of days of physical activity
Časové okno: Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
Three types of physical activity will be reported on: vigorous, moderate, and walking.
Participants will report how many days they did vigorous physical activities (like heavy lifting, digging, aerobics, or fast bicycling), how many days they did moderate (carrying light loads, bicycling at a regular pace, doubles tennis), and how many days they walked for at least 10 minutes during the last 7 days.
|
Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
Change in Score of Self Efficacy Fruits and Vegetables Questionnaire
Časové okno: Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
This questionnaire consists of 10 statements.
The participant must rate how confident they are about each of the statements.
The responses range from 0 (not at all sure) to 3 (very sure).
The total score ranges from 0-30.
The higher the score, the more confident the participant is about incorporating fruits and vegetables into their lifestyle.
|
Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
Change in Score of Self Efficacy Exercising Questionnaire
Časové okno: Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
This questionnaire consists of 11 statements.
The participant must rate how confident they are about each of the statements.
The responses range from 0 (not at all sure) to 3 (very sure).
The total score ranges from 0-30.
The higher the score, the more confident the participant is about incorporating exercise into their lifestyle.
|
Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
Change in Intrinsic Motivation for Eating Fruits and Vegetables
Časové okno: Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
In the format of a questionnaire, participants are asked to indicate the extent to which each reason is true for them, using a 7-point scale.
Why they eat fruits and vegetables (from a list of 17 reasons).
Each individual question is assessed separately, so no total range is given.
|
Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
Change in Intrinsic Motivation for Exercising
Časové okno: Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
In the format of a questionnaire, participants are asked to indicate the extent to which each reason is true for them, using a 7-point scale.
Why they choose to exercise (from a list of 15 reasons).
|
Baseline (Day 0), Day 30 +/- 7 days post-intervention
|
Self Efficacy in Seeking Mental Health Treatment (SESMHC)
Časové okno: Immediately post-simulation (Day 0)
|
This questionnaire consists of 9 statements.
Participants are asked to rate how confident they are about each of the statements.
Their responses range from 0 (no confidence) to 4 (complete confidence).
The total score ranges from 0-36.
The higher the score, the more confident the participant is about seeking mental health care.
|
Immediately post-simulation (Day 0)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Antoinette Shoenthaler, EdD, NYU Langone Health
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 19-00460
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- Protokol studie
- Plán statistické analýzy (SAP)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Virtual Education Simulation
-
University of BaselSwiss National Science Foundation; Universitäre Psychiatrische Kliniken (UPK)... a další spolupracovníciZatím nenabíráme
-
Sunnybrook Health Sciences CentreZatím nenabírámeVzdělávací problémy | Simulace fyzické nemoci | Lékařské pohotovostiKanada
-
University of Colorado, DenverUniversity of Kansas Medical Center; Children's Mercy Hospital Kansas CityNáborHPV infekce | Preventivní zdravotní službySpojené státy
-
US Department of Veterans AffairsIndiana University School of MedicineDokončeno
-
Pamukkale UniversityDokončenoOnemocnění vestibulárních nervůKrocan
-
Aveiro UniversityNeznámýBolest krkuPortugalsko
-
Hospital Universitari Vall d'Hebron Research InstituteUniversitat Autonoma de BarcelonaNáborFibromyalgieŠpanělsko
-
University of South FloridaNational Cancer Institute (NCI)StaženoDětská rakovinaSpojené státy
-
Selcuk UniversityDokončenoPraxe založená na důkazechKrocan
-
Johns Hopkins UniversityDokončenoFibrilace síní | ChováníSpojené státy