- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07313540
Faisabilité d'une intervention par application smartphone en milieu communautaire : une étude pilote pré-test/post-test
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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Wei-Chen Lee, PhD
- Numéro de téléphone: 409-747-2649
- E-mail: weilee@utmb.edu
Lieux d'étude
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Texas
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Galveston, Texas, États-Unis, 77555
- Recrutement
- University of Texas Medical Branch, Galveston
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Contact:
- Wei-Chen Lee, PhD
- Numéro de téléphone: 409-747-2649
- E-mail: weilee@utmb.edu
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility of a smartphone app intervention
Délai: 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
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Wei-Chen Lee, PhD, University of Texas Medical Branch, Galveston
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 23-0082
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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