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- Klinische proef NCT05379504
Vermindering van aan COVID-19 gerelateerde handicaps bij oudere volwassenen die op het platteland wonen met behulp van slimme technologie
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Missouri
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Columbia, Missouri, Verenigde Staten, 65211
- University of Missouri
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
Inclusiecriteria:
- Ouder dan 65 jaar, woonachtig in een landelijke provincie, moeite hebben met ten minste 1 zelfzorgtaak of 2 dagelijkse levenstaken, internettoegang hebben, in staat zijn om te staan met of zonder hulp
Uitsluitingscriteria:
- Levensverwachting van minder dan een jaar, Ernstige cognitieve stoornissen (mini-testscore voor mentale toestand <17), Leven in een instelling die zorg verleent, Katz ADL-score van 6, Thuis fysiotherapie, ergotherapie of verpleging ontvangen, In het ziekenhuis zijn opgenomen meer dan drie keer in de voorgaande 12 maanden Plan om binnen het komende jaar van woning te veranderen
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Zelfmanagement
De gedragsveranderingsmodus van de 5A [39] vormt het raamwerk voor de zelfmanagementinterventie.
Door de integratie van de zelfmanagementinterventie en het sensorsysteem worden de vijf A's aangepakt.
Er zijn minimaal vier interventiesessies met elk beroep in de gezondheidszorg (OT, RN en SW) voor 12 bezoeken per deelnemer.
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De zelfmanagementinterventie wordt in de loop van een jaar uitgevoerd.
Er zijn minimaal vier interventiesessies met elk zorgberoep (OT, RN en SW) voor 12 bezoeken per deelnemer.
Het team (OT, RN en SW) komt gedurende de eerste 2 maanden twee keer bijeen om een leidende interventionist te bepalen op basis van de SMART-doelen en aandachtspunten van de deelnemer.
De leidende interventionist heeft drie extra sessies met de deelnemer en is de contactpersoon voor waarschuwingen en berichten van het sensorsysteem.
Goal Attainment Scaling [83] zal worden afgenomen tijdens het driemaandelijkse interview om de voortgang van de deelnemers op de SMART-doelen te beoordelen.
Deze maatregel wordt samen met de deelnemer afgenomen, zorgt voor verdere verantwoording, biedt de deelnemer gelegenheid tot reflectie op de voortgang en is een concrete maatstaf voor 'succes' van de zelfmanagementinterventie.
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Actieve vergelijker: Gezondheidsopleiding
De deelnemer die is gerandomiseerd naar de standaardarm voor gezondheidseducatie, krijgt de interventie in maand 1 en vervolgens in maand 3, 6, 9 en 12.
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Deelnemers die gerandomiseerd zijn naar de standaardarm voor gezondheidseducatie, krijgen de interventie in maand 1 en vervolgens in maand 3, 6, 9 en 12 (samenvallend met de driemaandelijkse interviews).
De deelnemer gebruikt de tablet en het telehealth-platform om het interview en de educatieve sessie met onderzoeksmedewerkers te voltooien.
De inhoud van deze sessies zal gericht zijn op het helpen van de deelnemer (en familielid/verzorger indien van toepassing) om hun gezondheidsgegevens te begrijpen, hen te helpen bij eventuele technologische problemen en de deelnemer voorlichting te geven over hun aandoening(en) en alle gevraagde hulpmiddelen.
Onderzoekspersoneel zal ook eventuele aanvullende gezondheidsvoorlichting geven als er veranderingen in de omstandigheden of nieuwe diagnoses zijn na een bezoek van een externe zorgverlener.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Katz ADL Index
Tijdsspanne: 1 year
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The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, assesses functional status as a measurement of the client's ability to perform activities of daily living independently.
The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding.
Clients are scored yes/no for independence in each of the six functions.
A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
This scale ranges from 0 to 6.
This measure is the calculated change in score from baseline to post-intervention.
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1 year
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Change in PROMIS-43
Tijdsspanne: 1 year
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PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS-43 is a collection of 6-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. Each short form is scored as a T-score, with a score of 50 being average. This scale is 0 to 100. Higher scores indicate more (anxiety, depression, etc) and lower scores indicate less. This measure is the change in the T-score from baseline to post-intervention. A positive change in T-score is different for each sub-domain. Each will be indicated below in the row title. |
1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Hospital Anxiety and Depression Scale
Tijdsspanne: 1 year
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The Hospital Anxiety and Depression Scale is a two dimension scale developed to identify depression and anxiety.
There are 14 items.
The respondent rates each item on a 4 point scale ranging from 0 (absence) to 3 (extreme presence).
Some questions are inversely scored.
This outcome was assessed at baseline and post-intervention.
This measure is the change in score on the scale.
The overall range of scores is 0 to 42.
Anxiety and depression domains are reported separately below.
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1 year
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Change in Canadian Occupational Performance Measure
Tijdsspanne: 1 year
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The COPM is administered by an occupational therapy practitioner.
The participant ranks their five most important occupations that they currently have difficulty with.
Then they rate their current performance and satisfaction with that performance on a scale of 1-10.
The score on those five occupations are averaged to get a score of self-rated occupational performance and self-rated satisfaction with performance.
The scores on both scales can range from 0 to 10.
This measure is the change from baseline to post-intervention on both scores, reported separately below.
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1 year
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Change in Patient Activation Measure
Tijdsspanne: 1 year
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The Patient Activation Measure® is a 13-item survey that assesses an individual's knowledge, skills and confidence integral to managing one's own health and healthcare.
The participants rates how much they agree or disagree (1-4 scale) with 13 statements.
Using a licensed tool, a score ranging 0-100 is calculated.
This measure is the change in that score from baseline to post-intervention.
A positive change score means improvement.
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1 year
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Rachel M Proffitt, OTD, University of Missouri-Columbia
Publicaties en nuttige links
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