- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05057364
Heart Smart: A Virtual Self-Management Program for Homebound People With Heart Failure
7. marts 2022 opdateret af: Sara Frye, MS OTR/L ATP, University of Pennsylvania
The purpose of this capstone project is to pilot Heart Smart, a virtual group program to improve self-efficacy for self-management skills for homebound people with heart failure.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this capstone project is to pilot Heart Smart, a virtual group program to improve self-efficacy for self-management skills for homebound people with heart failure.
Heart Smart will provide synchronous virtual group education to homebound people with heart failure receiving services from Penn Medicine at Home.
The primary clinical goal is to improve self-efficacy for heart failure self-management and improve their knowledge of heart failure self-management strategies.
Secondary outcomes will explore the feasibility of the program by exploring technology, adherence and satisfaction with the program.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
5
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
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Bala-Cynwyd, Pennsylvania, Forenede Stater, 19004
- Penn Medicine at Home
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-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosis of heart failure
- Receiving home health care from Penn Medicine at Home at time of screening.
- Technology capabilities to participate in the program (laptop or tablet with a camera, internet access).
- Able to read and write in English.
- Cognitive ability to participate in the program if the participant is able to score12/15 on the Montreal Cognitive Assessment (MoCA) 5 Minute Phone Test.
Exclusion Criteria:
- Hearing impairment that impacts communication.
- Previous experience receiving occupational therapy services from the principal investigator.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Heart Smart Group
Receives Heart Smart Intervention
|
The Heart Smart Intervention is a 6 week virtual program consisting of one individual technology training session followed by 5 one hour group education sessions.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Self-Efficacy Measure for Chronic Disease (SEMCD)
Tidsramme: At first and final sessions (weeks 1 and 6)
|
This self-report scale has 6 items which are each rated on a scale of 1 (not at all confident) to 10 (totally confident).
The score for the scale is the mean of the scores for the six items.
Possible scores are 1-10 with higher scores indicating higher self-efficacy.
This scale is an appropriate outcome measure for a heart failure self-management group because it was designed to measure self-efficacy in people with chronic conditions such as heart failure and has undergone psychometric evaluation.
This scale is free to use without permission.
Administration takes less than 10 minutes.
|
At first and final sessions (weeks 1 and 6)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Tidsramme: At first and final sessions (weeks 1 and 6)
|
This 23-item, Likert scale, self-report heart failure specific outcome measure.
The instrument measures six domains: physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
This instrument is appropriate because it is designed for use for people with heart failure, will give an indication of participant heart failure severity for demographic purposes, and has a validated self-efficacy component.
This scale requires a license which has been obtained for this pilot project.
Administration takes less than 10 minutes.
Scores range from 0 to 100 with higher scores indicating higher cardiac health status.
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At first and final sessions (weeks 1 and 6)
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Change in Atlanta Heart Failure Knowledge Test V3 (AHFKT)
Tidsramme: At first and final sessions (weeks 1 and 6)
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This 30 item multiple choice measure of heart failure self-management knowledge yields scores 0-30 which are commonly reported as a percentage (higher scores indicate more knowledge).
Content validity was established through a panel of expert heart failure nurses.
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At first and final sessions (weeks 1 and 6)
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Attendance
Tidsramme: At each weekly session for 6 weeks
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The number of participants at each meeting will be recorded.
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At each weekly session for 6 weeks
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Minutes of training
Tidsramme: This will be recorded in the first session at week 1.
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The number of minutes spent in the pre-training session will be recorded.
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This will be recorded in the first session at week 1.
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Participant Satisfaction
Tidsramme: At the final session on week 6
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Participants will answer three likert scale questions.
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At the final session on week 6
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Technology failures
Tidsramme: At each weekly session for 6 weeks.
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Total number of minutes missed per participant per session.
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At each weekly session for 6 weeks.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Sara Frye, MS OTR/L ATP, Penn Medicine at Home Professional Development Department
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.
Generelle publikationer
- Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3.
- Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.
- Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
- Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
- Butler J, Khan MS, Mori C, Filippatos GS, Ponikowski P, Comin-Colet J, Roubert B, Spertus JA, Anker SD. Minimal clinically important difference in quality of life scores for patients with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Jun;22(6):999-1005. doi: 10.1002/ejhf.1810. Epub 2020 Apr 2.
- Butts B, Higgins M, Dunbar S, Reilly C. The Third Time's a Charm: Psychometric Testing and Update of the Atlanta Heart Failure Knowledge Test. J Cardiovasc Nurs. 2018 Jan/Feb;33(1):13-21. doi: 10.1097/JCN.0000000000000413.
- Spertus JA, Jones PG, Kim J, Globe D. Validity, reliability, and responsiveness of the Kansas City Cardiomyopathy Questionnaire in anemic heart failure patients. Qual Life Res. 2008 Mar;17(2):291-8. doi: 10.1007/s11136-007-9302-5. Epub 2007 Dec 29.
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 (Faktiske)
28. september 2021
Primær færdiggørelse (Faktiske)
31. december 2021
Studieafslutning (Faktiske)
31. december 2021
Datoer for studieregistrering
Først indsendt
31. august 2021
Først indsendt, der opfyldte QC-kriterier
15. september 2021
Først opslået (Faktiske)
27. september 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. marts 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 849646
Plan for individuelle deltagerdata (IPD)
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