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Caregiver BurnoutPhase 1CuidaTXTNCT04316104

CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos

A Phase 1 study testing CuidaTXT in people with Caregiver Burnout, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Caregiver Burnout
What is being tested?
CuidaTXT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
1 Jul 2021to 10 Mar 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kansas Medical Center

    Kansas City, Kansas, 66103

Other trials in United States

About this study

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.

Read the detailed 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.

Being tested
CuidaTXT
Keywords
Dementia, Caregiver, mHealth, Stress, Latino, Disparities
Medical subject headings
Caregiver Burden, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CuidaTXTBehavioural

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

Study groups in NCT04316104
Study groupRoleWhat they receive
CuidaTXTExperimentalThis 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.
Receives: Behavioral: CuidaTXT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the 6 months of the intervention period

  2. 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.

    Measured: During the 6 months of the intervention period

  3. 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.

    Measured: 6 months from baseline

  4. 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.

    Measured: During the 6 months of the intervention period

  5. 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.

    Measured: 6 months from baseline

  6. 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.

    Measured: During the 6 months of the intervention period

  7. 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).

    Measured: 6 months from baseline

Secondary outcomes (4)

  1. 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.

    Measured: Baseline and 6 months from baseline

  2. 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.

    Measured: Baseline and 6 months from baseline

  3. 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.

    Measured: Baseline and 6 months from baseline

  4. 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.

    Measured: Baseline and 6 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2020
  2. Study start1 Jul 2021
  3. Primary completion10 Mar 2022
  4. Study completion10 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04316104
Sponsor's protocol ID
STUDY00144478
Other IDs
1R21AG065755-01A1
Acronym
CuidaTXT
Status last verified
Oct 2022
First submitted
18 Mar 2020
Last updated
7 Nov 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The final dataset will include caregivers' demographic and behavioral data from interviews as well as metrics, direct observation and survey data on feasibility, acceptability and preliminary efficacy of CuidaTXT. Along with the dataset, the team will create a code book documenting all variables. Although the data analytic files will not have direct identifiers (only study identification numbers), the possibility of deductive disclosure of subjects with certain clinical characteristics may remain. To safeguard against the unlikely event of deductive disclosure, the team will only make the data files and codebook available to other researchers on a case-by-case basis.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CuidaTXT in people with Caregiver Burnout, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Able to Opt Into CuidaTXT (Enrollment Feasibility) (time frame: During the 6 months of the intervention period). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04316104.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.

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