CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos

Caregiver Burnout Clinical Trial

— CuidaTXT  

Official title:

CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316104
• Other study ID #: STUDY00144478
• Secondary ID: 1R21AG065755-01A
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2021
• Est. completion date: March 10, 2022

Study information

• Verified date: October 2022
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 10, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Dementia

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change From Baseline to 6 Months in Alzheimer's Disease Knowledge	Epidemiology/Etiology Disease Scale: 14-item, true/false scale takes approximately 5-10 min to complete. An example of an item is "There is no cure for Alzheimer's". Each correct answer is scored as 1 point and each incorrect answer as 0 points. Points are summed up for a total score, which ranges from 0 to 14. Higher scores mean more questions answered correctly. The current outcome is the scales' score at month 6 minus the score at baseline.	Baseline and 6 months from baseline
Secondary	Change From Baseline to 6 Months in Caregiver Social Support	Interpersonal Support Evaluation List-12 (ISEL-12): 12-item instrument that that yields a total score that describes overall perceived social support, and three subscales representing perceived availability of appraisal (advice or guidance), belonging (empathy, acceptance, concern), and tangible (help or assistance, such as material or financial aid) social support. Each item is rated either definitely false (1), probably false (2), probably true (3), or definitely true (4). Scores are summed for the total scale (12-48) and subscales (4-16). Higher scores mean higher social support for each scale. The current outcome is the scales' score at month 6 minus the score at baseline.	Baseline and 6 months from baseline
Secondary	Change From Baseline to 6 Months in Caregiving Self-efficacy	Preparedness for caregiving scale: The Preparedness for Caregiving Scale is a caregiver self-rated instrument that consists of eight items that asks caregivers how well prepared they believe they are for multiple domains of caregiving. Preparedness is defined as perceived readiness for multiple domains of the caregiving role such as providing physical care, providing emotional support, setting up in-home support services, and dealing with the stress of caregiving. Responses are rated on a 5 point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The total score is the sum of all items divided by the number of items (eight), and ranges from 0 to 4. The higher the score the more prepared the caregiver feels for caregiving. An example of an item is: "How well prepared do you think you are to take care of your family member's physical needs?". The current outcome is the scales' score at month 6 minus the score at baseline.	Baseline and 6 months from baseline
Secondary	Change From Baseline to 6 Months in Caregiver Depression	10-item Center for Epidemiologic Studies-Depression scale (CES-D-10): This is a 10-item, self-report rating scale that measures characteristic symptoms of depression in the past week (e.g. depression, loneliness, restless sleep). Each item is rated on a 4-point scale, from 0 (rarely or none of the time) to 3 (most or all of the time) with positively worded items (items 5 and 8) reverse scored. Items yield summary scores that range from 0 to 30, with higher scores indicating higher severity. An example of an item is: "I was bothered by things that usually don't bother me". The current outcome is the scales' score at month 6 minus the score at baseline.	Baseline and 6 months from baseline