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- Klinische proef NCT07313540
Haalbaarheid van een smartphoneapplicatie-interventie in gemeenschapsinstellingen: een pilotstudie met voor- en nameting
Haalbaarheid van een smartphone-app-interventie in gemeenschapsinstellingen: Een pilotstudie met voor- en nameting
The objective of this project is to test the feasibility of using a smartphone app in a community setting through collaborating with community-based organizations. The app is called utmbHealthyBrain and it has three activities: (1) drawing, (2) Tai-Chi and meditation, and (3) prayer reading. It also has a "share" function to enable users to interact with their family and friend. These activities can be translated to humans' well-beings such as a more stable emotion, more muscle movement, and better social engagement. This app does not collect any personal data and users are not required to register an account either. The overall study period is 6 weeks including one introduction session (week 1), four weeks of intervention (week 2 to 5), and final feedback session (week 6).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This study will conduct primary data collection on 20 individuals aged 50+ and another 20 who are their caregivers regarding the use of a smartphone application (app) to promote mental well-being. The aging population is growing rapidly from 52 million in 2018 to 95 million by 2060. Approximately 34.2 million Americans have provided unpaid care to an adult age 50 or older. While 82% of them care for one adult, about 15% care for 2 adults and 3% for 3 or more adults. This number is expected to increase as the population ages. Deteriorating health of care recipients and caregivers is a critical issue that may be delayed by the use of a smartphone app to improve mental and emotional well-beings.
The objective of this proposed project is through collaborating with community-based organizations to test the acceptability and feasibility of a smartphone app intervention. We will collaborate with the community-based organization (i.e., UTMB OLLI and Libbie's Place) to announce the study by flyers and request RSVP to the study investigator. The investigator will provide instructions on using the smartphone app to potential participants and obtain participant's written consent to the study. After consenting, 20 pairs of older adults and their caregivers will fill out a mood test, download the app to their phone, and use it at least three times a week for four weeks. Participants will be required to keep their utilization log and fill out the post-intervention mood test and the feedback survey after four weeks of participation.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Wei-Chen Lee, PhD
- Telefoonnummer: 409-747-2649
- E-mail: weilee@utmb.edu
Studie Locaties
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Texas
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Galveston, Texas, Verenigde Staten, 77555
- Werving
- University of Texas Medical Branch, Galveston
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Contact:
- Wei-Chen Lee, PhD
- Telefoonnummer: 409-747-2649
- E-mail: weilee@utmb.edu
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Individuals aged 50+ who has a primary source of assistance (no age limitation for the caregiver)
- Both care recipient and caregiver can participate in the study for six weeks in total,
- Both care recipient and caregiver can read, listen, write, and speak English
- Both care recipient and caregiver have a personal smartphone.
Exclusion Criteria:
- People who are diagnosed with any middle to severe cognitive symptoms (dementia or Alzheimer's Disease) or any psychiatric disease (depression, bipolar, PTSD, Schizophrenia, anxiety disorders, eating disorders)
- People who are at hospice care
- People who plan to move out of the current area in one year, and (4) people younger than 50 (but no age limitation for caregivers)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Intervention Group
Twenty pairs of care recipients and caregivers (total: 40 people) will be recruited to the study and required to download the app to their phone and use it three times a week for four weeks. Tools to collect data include (1) one participation log, (2) two mood tests before and after the intervention, and (3) one feedback survey after the intervention. |
a wellness product related to relaxation and stress management and presents a low risk to the safety of users and other persons |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Feasibility of a smartphone app intervention
Tijdsspanne: 3 times per week for 4 weeks
|
Feasibility will be assessed by participant adherence to the smartphone app intervention, defined as completion of activities three times per week. |
3 times per week for 4 weeks
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Wei-Chen Lee, PhD, University of Texas Medical Branch, Galveston
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 23-0082
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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