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临床试验/NCT04316104
NCT04316104已完成1 期

CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年7月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Percentage of Participants Able to Opt Into CuidaTXT (Enrollment Feasibility)

研究概览

简要总结

Latino families with dementia experience substantial disparities in access to caregiver support compared to their non-Latino white peers, putting them at an increased risk for negative emotional, physical and financial outcomes. This R21 will address this research gap by 1) Developing a culturally and linguistically appropriate text message intervention for caregiver support among Latino family caregivers of individuals with dementia and 2) Testing the feasibility and acceptability of CuidaTXT, a multicomponent text message caregiver support intervention culturally and linguistically tailored for the Latino community.

详细描述

Latino relatives of individuals with dementia are less likely than non-Latino whites to have access to caregiver support. Text messaging can dramatically enhance the reach of effective culturally and linguistically tailored caregiver support interventions. However, to our knowledge, no text message interventions exist to provide caregiver support among caregivers of individuals with dementia. Text message interventions can capitalize on the fact that Latinos own cellphones and use them to text at a higher rate than non-Latino whites. The overall aim of this proposal is to develop and test the first text message intervention for caregiver support of individuals with dementia among Latinos. This intervention, CuidaTXT [Spanish for self-care and texting], will be available in English and Spanish, incorporate two-way messaging and will tailor text messages to the preferences of Latino caregivers. CuidaTXT will be multicomponent and based on the Stress Process Framework as supported by evidence. The intervention will incorporate social support and coping components including dementia education, problem-solving skills training, social network support, care management and referral to community resources. This research corresponds with Stage 1 of the NIH Stage Model for Behavioral Intervention Development. In Aim 1, researchers will develop a culturally and linguistically appropriate text message intervention for caregiver support among Latino family caregivers of individuals with dementia using user-centered design methods. In Aim 2, researchers will test the feasibility and acceptability of CuidaTXT during six months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Spanish and English-speaking individuals
  • Over the age of 18
  • Identify as Latino
  • Report providing hands-on care for a relative who has been given a clinical or research dementia diagnosis
  • Care recipient has an AD-8 screening score greater than or equal to 2, indicating cognitive impairment
  • Self-report being able to read and write
  • Self-report owning a cell phone with a flat fee and use it at least weekly for texting

排除标准

  • 未提供

研究组 & 干预措施

CuidaTXT

Experimental

This intervention, CuidaTXT [Spanish for self-care and texting], will be available in English and Spanish, incorporate two-way messaging and will tailor text messages to the preferences of Latino caregivers. CuidaTXT will be multicomponent and based on the Stress Process Framework as supported by evidence. The intervention will incorporate social support and coping components including dementia education, problem-solving skills training, social network support, care management and referral to community resources.

干预措施: CuidaTXT (Behavioral)

结局指标

主要结局

Percentage of Participants Able to Opt Into CuidaTXT (Enrollment Feasibility)

时间窗: During the 6 months of the intervention period

Metrics of the percentage of participants able to opt into CuidaTXT. Each participant the researcher is able to enroll into the CuidaTXT intervention via entering their name and phone number in the software is counted here. The result of being enrolled successfully is that the participant reports receiving text messages to the research team during the call when the enrollment takes place. Participants for whom the name and phone number is not able to be entered in the software, or who report not receiving text messages upon entering their information in the software are not counted, as this would be an unsuccessful attempt of enrollment into CuidaTXT.

Percentage of Participants Who Texted the STOP Keyword to Opt Out/Quit the Intervention

时间窗: During the 6 months of the intervention period

Metrics of percentage of participants who texted STOP keyword. Participants are instructed during the course of the intervention to send the keyword STOP if they want to quit the intervention. The research team counts each participant who sends the keyword STOP, as seen on the software report, and calculates a percentage among all the participants.

Number of Participants Who Reported Experiencing Technical Problems With the Intervention

时间窗: 6 months from baseline

Survey open-ended reports of technical problems. A question in the 6 month survey asks whether participants experienced any technical problems with CuidaTXT during the study. The response options are Yes or No. The outcome is the number of participants who responded Yes to this question among all the participants who completed the 6 month survey.

Thoroughness With Which Participants Read Intervention Text Messages (Engagement Feasibility)

时间窗: 6 months from baseline

Survey responses of percentage of participants who report reading most or all texts thoroughly. The 6 month survey asks participants to what extent they have read the text messages. There are 3 response options: 'I read through the text messages thoroughly most times' in the follow-up survey as opposed to 'I took only a short look at the text messages most times', or 'I did not read the text messages most times'. The current outcome indicates the number of participants who responded 'I read through the text messages thoroughly most times' among all participants that completed the 6 month survey.

Satisfaction With Intervention

时间窗: 6 months from baseline

Research team-developed one item with a 4-item Likert scale on satisfaction with intervention, higher scores meaning higher satisfaction. In the 6 month survey, participants were asked what their levels of satisfaction are regarding the intervention as a whole. Options ranged from Not at All (1) to Extremely (4).

Average of the Percentage of Messages Sent by Each Participant to Interact With the Intervention That Were Keywords

时间窗: During the 6 months of the intervention period

Metrics of the percentage of messages sent by participants to interact with the intervention that were keywords. Participants were able to send text messages to receive tailored text messages back about topics to cover their needs. Text messages they could send include chat messages with a live coach (e.g., like any text message people send ordinarily) or keyword-driven messages (a specific keyword that triggers an automatic message). The research team counted the number of messages in the software report that were keywords and chat messages and calculated the percentage of those that were keywords and later calculated the average of that percentage for all participants.

Percentage of Participants Who Interacted With the Intervention by Sending at Least One Text Message (Engagement Feasibility)

时间窗: During the 6 months of the intervention period

Metrics on percentage of participants who sent at least one text message. The CuiaTXT intervention consists of participants receiving and sending messages to the program. The research team has access to the CuidaTXT software, where they can see the messages each participant has sent to the program. This metric is the number of participants who sent at least one text message to CuidaTXT among all the participants.

次要结局

  • Change From Baseline to 6 Months in Alzheimer's Disease Knowledge(Baseline and 6 months from baseline)
  • Change From Baseline to 6 Months in Caregiver Social Support(Baseline and 6 months from baseline)
  • Change From Baseline to 6 Months in Caregiving Self-efficacy(Baseline and 6 months from baseline)
  • Change From Baseline to 6 Months in Caregiver Depression(Baseline and 6 months from baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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