- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06817122
La herramienta "hablemos de tecnología" para apoyar la toma de decisiones sobre el uso de la tecnología
Estudio mecanicista de la intervención de comportamiento diádica "hablar de la tecnología" para apoyar la toma de decisiones sobre el uso de la tecnología
The goal of this research is to educate people about different technologies to support care at home when someone is experiencing memory difficulties. "Let's Talk Tech" is a new tool to educate people about technologies commonly used to support care and monitor safety, and help families talk about their feelings about them to understand each other's perspectives. The goal of this clinical trial is to learn if "Let's Talk Tech" helps people feel more prepared to make decisions about technologies.
Researchers will compare Let's Talk Tech to usual care (no intervention) to see if Let's Talk Tech increases peoples' preparedness and confidence to make decisions about technologies.
All participants will:
- Use the Let's Talk Tech web application together with their study partner that takes up to an hour or do nothing.
- Complete two surveys. The second survey will be taken within 2 weeks of the first.
One participant in each pair will also take a 3rd short survey 3 months after the first.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The goal of this research is to help families understand digital health technology options to support dementia care at home so they can negotiate immediate decisions and future use in an informed way. This is a mechanism-focused trial of Let's Talk Tech (LTT), a single-use, self-administered intervention in the form of a web application. It targets education and interpersonal communication processes to enable informed decision making and planning for technology use that relieves care partners of the burden of making decisions without awareness of the person's preferences. Participants are people living with mild Alzheimer's disease (AD) and AD-related dementias (PLWD) or mild cognitive impairment (MCI) and a care partner. The 120 enrolled dyads (60 per study group) will be randomly assigned to receive either the intervention or usual care control. The intervention is self-administered. All participants will complete measures at baseline and at post-test (2 weeks), and care partners will also complete them 3 months later. Aim 1 will test if LTT compared with usual care improves the hypothesized mechanisms of change that are care partners' technology awareness, understanding, communication satisfaction, and intention to honor the PLWD/MCI's preferences, as well as both care partner- and PLWD/MCI-reported dyadic alignment. Aim 2 will examine if and how those hypothesized mechanisms of change improve the post-test and 3-month primary outcomes of care partner preparedness, decisional conflict, and decision making confidence, and secondary outcomes of PLWD/MCI and care partner sharing of technology preferences beyond the dyad and their confidence that PLWD/MCI's preferences will be honored. Exploratory Aim 3 will examine how, with whom, and for what purpose dyad members share technology preferences and explore factors that vary for those who shared with providers vs. family/friends, with the hope of learning how to expand the reach of this intervention to activate dyads' entire care networks.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Washington
-
Seattle, Washington, Estados Unidos, 98105
- University of Washington
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria for Patients:
- have mild cognitive impairment (MCI) or mild dementia
- age 55 or older
- able to understand and speak English
Inclusion Criteria for Co-participants:
- be identified by the patient as their primary support person
- age 18 or older
- able to understand and speak English
- able to complete LTT together with their study partner at the same time
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Let's Talk Tech intervention
The intervention group will complete the single use self-administered Let's Talk Tech intervention together as a dyad. |
Let's Talk Tech is a self-administered dyadic education and communication tool delivered as a web application to support shared decision making about technology use. |
|
Sin intervención: Usual care
This control group will receive usual care, which means they will complete no intervention. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Preparedness to make technology decisions
Periodo de tiempo: baseline, 2-week post-test and 3 months
|
This is one of the three primary outcomes that are not mechanisms of change variables. Participant rates on a 5-point Likert scale [1="Strongly agree" to 5="Strongly disagree"] how much they agree with the statement that they feel prepared to make decisions about technology use for their study partner. |
baseline, 2-week post-test and 3 months
|
|
Decisional Conflict Scale
Periodo de tiempo: baseline, 2-week post-test and 3 months
|
This is one of the three primary outcomes that are not mechanisms of change variables. The Decisional Conflict Scale is a 16-item scale with 5 response categories [0= "Strongly agree" to 4="Strongly disagree"]. Higher scores reflect higher decisional conflict in decision making. |
baseline, 2-week post-test and 3 months
|
|
Decision Making Confidence Scale (adapted)
Periodo de tiempo: baseline, 2-week post-test and 3 months
|
This is one of the three primary outcomes that are not mechanisms of change variables. This is a six-item scale with 5 response categories [0="Not confident at all" to 4= "Very confident"]. Higher scores reflect higher confidence in decision making. |
baseline, 2-week post-test and 3 months
|
|
Technology awareness
Periodo de tiempo: baseline and 2-week post-test
|
Participant rates on a 5-point Likert scale [1="Very aware" to 5="Very unaware"] how aware they are about technologies available to support their partner's care and safety. |
baseline and 2-week post-test
|
|
Technology understanding
Periodo de tiempo: baseline and 2-week post-test
|
4 items assess perceived understanding of each of 4 technologies featured in the intervention [1="Not at all" to 5="Completely"]. |
baseline and 2-week post-test
|
|
Perception of PLWD/MCI's technology understanding
Periodo de tiempo: baseline and 2-week post-test
|
4 items assess care partner's perception of how well their study partner understands of each of 4 technologies featured in the intervention [1="Not at all" to 5="Completely"]. |
baseline and 2-week post-test
|
|
Satisfaction with dyadic communication about technology
Periodo de tiempo: baseline and 2-week post-test
|
Participant rates on a 5-point Likert scale [1="Very satisfied" to 5="Very dissatisfied"] how satisfied they are with their discussion with their study partner about using technology to support their care or safety. |
baseline and 2-week post-test
|
|
Intention to honor preferences
Periodo de tiempo: baseline and 2-week post-test
|
Participant rates on a 5-point Likert scale [1="Very likely" to 5="Very unlikely"] how likely they are to honor their partner's preferences for how technology is used in their care. |
baseline and 2-week post-test
|
|
Dyadic alignment about technology use
Periodo de tiempo: baseline and 2-week post-test
|
Participant is asked how much they agree with their partner about using technologies to support their care [1="Not at all" to 5="Completely"]. |
baseline and 2-week post-test
|
|
Had conversation about technology
Periodo de tiempo: baseline and 2-week post-test
|
Participant answers yes, no or unsure if they've ever had a conversation with their study partner about technology to support care or safety. |
baseline and 2-week post-test
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Shared technology preferences
Periodo de tiempo: baseline, 2-week post-test and 3 months
|
Participant answer yes or no if they have ever shared the PLWD/MCI's preferences about technologies to support their care with anyone else. |
baseline, 2-week post-test and 3 months
|
|
Confidence preferences will be honored
Periodo de tiempo: baseline, 2-week post-test and 3 months
|
Participant rates on a 5-point Likert scale [1=Strongly agree to 5=Strongly disagree] about their belief the PLWD/MCI's choices about these technologies will be honored. |
baseline, 2-week post-test and 3 months
|
|
Satisfaction with involvement of primary participant in technology use decisions
Periodo de tiempo: baseline, 2-week post-test and 3 months
|
Participant rates on a 5-point Likert scale [1="Very satisfied" to 5="Very dissatisfied"] how satisfied they are with how involved the primary participant is in decisions about technology to support their care. |
baseline, 2-week post-test and 3 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Clara Berridge, PhD, University of Washington
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Neoplasias
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Trastornos neurocognitivos
- Trastornos cognitivos
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Linfoma No Hodgkin
- Linfoma
- Enfermedades hemic y linfáticas
- Disfunción congnitiva
- Linfoma Folicular
- Demencia
Otros números de identificación del estudio
- STUDY00020570
- 1P30AG086562-01 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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