Trial Outcomes & Findings for CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos (NCT NCT04316104)

NCT ID: NCT04316104

Last Updated: 2022-11-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

During the 6 months of the intervention period

Results posted on

2022-11-07

Participant Flow

Participant milestones

Participant milestones
Measure
CuidaTXT
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Overall Study
STARTED
24
Overall Study
COMPLETED
21
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CuidTXT
n=24 Participants
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
21 Participants
n=99 Participants
Age, Categorical
>=65 years
3 Participants
n=99 Participants
Age, Continuous
52.6 years
STANDARD_DEVIATION 13.2 • n=99 Participants
Sex: Female, Male
Female
20 Participants
n=99 Participants
Sex: Female, Male
Male
4 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
24 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
Race (NIH/OMB)
White
7 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
15 Participants
n=99 Participants
Region of Enrollment
United States
24 participants
n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CuidTXT
n=24 Participants
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Percentage of Participants Able to Opt Into CuidaTXT (Enrollment Feasibility)
24 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CuidTXT
n=24 Participants
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Percentage of Participants Who Texted the STOP Keyword to Opt Out/Quit the Intervention
0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CuidTXT
n=21 Participants
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Number of Participants Who Reported Experiencing Technical Problems With the Intervention
2 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CuidTXT
n=24 Participants
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Percentage of Participants Who Interacted With the Intervention by Sending at Least One Text Message (Engagement Feasibility)
22 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CuidTXT
n=21 Participants
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Thoroughness With Which Participants Read Intervention Text Messages (Engagement Feasibility)
18 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CuidTXT
n=24 Participants
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Average of the Percentage of Messages Sent by Each Participant to Interact With the Intervention That Were Keywords
44.1 Percent of messages were keywords
Standard Deviation 30.6

PRIMARY outcome

Timeframe: 6 months from baseline

Population: Average satisfaction score in a 1-item scale that ranges from Not at All (1) to Extremely (4) satisfied.

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).

Outcome measures

Outcome measures
Measure
CuidTXT
n=21 Participants
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Satisfaction With Intervention
3.6 Average score
Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline and 6 months from baseline

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.

Outcome measures

Outcome measures
Measure
CuidTXT
n=21 Participants
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Change From Baseline to 6 Months in Alzheimer's Disease Knowledge
1.1 change in units on a scale
Standard Deviation 1.7

SECONDARY outcome

Timeframe: Baseline and 6 months from baseline

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.

Outcome measures

Outcome measures
Measure
CuidTXT
n=20 Participants
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Change From Baseline to 6 Months in Caregiver Social Support
1.0 Change in units of scale
Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline and 6 months from baseline

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.

Outcome measures

Outcome measures
Measure
CuidTXT
n=20 Participants
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Change From Baseline to 6 Months in Caregiving Self-efficacy
0.5 Change in units of scale
Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline and 6 months from baseline

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.

Outcome measures

Outcome measures
Measure
CuidTXT
n=20 Participants
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. CuidTXT: Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
Change From Baseline to 6 Months in Caregiver Depression
-3.4 Change in units of scale
Standard Deviation 5.2

Adverse Events

CuidTXT

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jaime Perales Puchalt

University of Kansas Alzheimer's Disease Research Center

Phone: 913-588-3716

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place