CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos

NCT04316104 | Completed Phase 1 Results

• 2 other identifiers: STUDY001444781R21AG065755-01A1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caregiver Burnout

Keywords

Dementia; Caregiver; mHealth; Stress; Latino; Disparities

Outcome Measures

Primary Outcomes (7)

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

  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.

  During the 6 months of the intervention period

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

  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.

  During the 6 months of the intervention period

• Number of Participants Who Reported Experiencing Technical Problems With the Intervention

  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.

  6 months from baseline

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

  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.

  During the 6 months of the intervention period

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

  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.

  6 months from baseline

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

  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.

  During the 6 months of the intervention period

• Satisfaction With Intervention

  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).

  6 months from baseline

Secondary Outcomes (4)

• 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

Study Arms (1)

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.

Behavioral: CuidaTXT

Interventions

CuidaTXT BEHAVIORAL

Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.

CuidaTXT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Dementia

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Jaime Perales Puchalt
• Organization: University of Kansas Alzheimer's Disease Research Center

jperales@kumc.edu

913-588-3716

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 20, 2020
• Study Start: July 1, 2021
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: November 7, 2022
• Results First Posted: November 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will become available on July 1st, 2022
• Access Criteria: Researchers requesting data will need to complete a request form outlining intended use of the data, and agree to use the data solely for this intended purpose. Prior to data release, researchers requesting data will be required to sign a confidentiality agreement specifying that they will not identify any individual participant, that they will use secure technology to safeguard the data, and that they will destroy or return the data after their analyses are completed.

Locations

US (1)