CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04316104
Collaborator
National Institute on Aging (NIA) (NIH)
20
1
1
12
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CuidTXT
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Supportive Care
Official Title:
CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: CuidTXT

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

Outcome Measures

Primary Outcome Measures

  1. Enrollment feasibility [During the 6 months of the intervention period]

    Metrics of the percentage of participants able to opt into CuidaTXT

  2. Opting out of intervention [During the 6 months of the intervention period]

    Metrics of percentage of participants who texted STOP keyword

  3. Technical problems [6 months from baseline]

    Survey open-ended reports of technical problems

  4. Engagement feasibility [During the 6 months of the intervention period]

    Metrics on percentage of participants who sent at least one text message

  5. Engagement feasibility [6 months from baseline]

    Survey responses of percentage of participants who report reading most or all texts

  6. Intervention component use [During the 6 months of the intervention period]

    Metrics of the number of specific keywords sent

  7. Satisfaction with intervention [6 months from baseline]

    Survey 5-item Likert scale on satisfaction with intervention, higher scores meaning higher satisfaction

  8. Suggestions for refinement [6 months from baseline]

    Survey open-ended reports of suggestions

Secondary Outcome Measures

  1. Alzheimer's Disease Knowledge [Baseline and 6 months from baseline]

    32. 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". Higher scores mean higher knowledge.

  2. Caregiver social support [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. Higher scores mean higher social support.

  3. Caregiving self-efficacy [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 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?"

  4. Caregiver depression [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"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kansas Medical Center Kansas City Kansas United States 66103

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT04316104
Other Study ID Numbers:
  • STUDY00144478
  • 1R21AG065755-01A1
First Posted:
Mar 20, 2020
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Kansas Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2021