Primary Health CareNCT02647814
Salud al Día: Engaging Latino Parents in Pediatric Primary Care
A study testing Salud al Día in people with Primary Health Care, run by Johns Hopkins University at 1 site in United States.
Trial summary
Objective: To conduct a pilot randomized controlled trial comparing the effectiveness of a parent support intervention consisting of periodic text messages and educational support (video, collateral materials),and usual care on the healthcare engagement of limited English proficient (LEP) Latino parents during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Health Care
- What is being tested?
- Salud al Día
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent or legal guardian of a singleton US-born infant ≤ 2 months of age
- Parent or legal guardian age 18 or older
- Parent or legal guardian self-identified as Latino/a
- Parent or legal guardian foreign-born
- Parental report of Spanish as their preferred healthcare language
- Plan to select Medicaid/Priority Partners insurance for their child with the Johns Hopkins Bayview Medical Center Children's Medical Practice as the primary care site
- Have a working cellular phone with text message capability and parent reports prior use of text messaging
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Objective: To conduct a pilot randomized controlled trial comparing the effectiveness of a parent support intervention consisting of periodic text messages and educational support (video, collateral materials),and usual care on the healthcare engagement of limited English proficient (LEP) Latino parents during participants' child's first year and to examine its impact on healthcare utilization and primary care quality.
Read the detailed description
Lessons learned in organizational engagement reveal a critical need to increase healthcare engagement among LEP Latino parents. LEP Latina mothers who were founding members of Latino Family Advisory Board (LFAB) at the Johns Hopkins Bayview Medical Center identified the health system knowledge that enabled participants to more effectively use the healthcare system as one of the key benefits of board membership. The gains in knowledge, skills, and confidence demonstrated in the LFAB evaluation mirror qualitative evaluation findings of other ambulatory care advisory boards, and reflect the concept of patient activation. Patient activation, a component of individual patient engagement, is defined as the patient's willingness to manage their health and healthcare based on understanding one's role in the care process and having the knowledge, skills, and confidence to do so. Interventions focused on increasing activation, using both in-person and mHealth support, have demonstrated efficacy and have led to improvement in health and healthcare quality. mHealth-based interventions have the ability to reach larger populations at lower cost, with the potential for increased tailoring and interactivity, especially as the use of cellular phones becomes nearly universal, even among low-income populations. For example, Text4baby, a perinatal health education program delivered through passive educational text messages, has demonstrated success at reaching low-income Spanish-speaking parents with positive user assessments.
A recent study of parent healthcare activation among low-income parents (conducted by PI: DeCamp) demonstrated that parent activation among parents whose preferred healthcare language was Spanish was significantly lower than that of parents whose preferred healthcare language was English. These findings further support targeting increasing the healthcare engagement of LEP Latino parents.
This novel intervention will integrate mobile health (mHealth) technology and culturally- and linguistically-tailored interpersonal support to increase healthcare engagement of LEP Latino parents and to enable participants to overcome barriers to effective healthcare access and use. Investigators hypothesize that this intervention will measurably increase parent healthcare engagement and that this will positively impact healthcare utilization, quality and the patient/family experience. Increasing healthcare engagement of LEP Latino families and demonstrating positive healthcare impact through a tailored, scalable intervention would create a foundation for larger-scale impact on healthcare disparities for Latino children and a model for increasing engagement of other vulnerable populations.
- Conditions
- Primary Health Care
- Being tested
- Salud al Día
- Keywords
- Parent activation, Text-messages, LEP, Latino populations, pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salud al DíaBehavioural
A pilot randomized controlled trial comparing the effectiveness of a parent support intervention consisting of periodic text messages and educational support (video, collateral materials),and usual care on the healthcare engagement of LEP Latino parents during their child's first year and to examine its impact on healthcare utilization and primary care quality.
| Study group | Role | What they receive |
|---|---|---|
| Salud al Día | Experimental | The participants in the intervention group will receive interactive text-messages with a link to support if needed for: clinic appointment reminders, follow-up on medicine and referral adherence, and illness care needs and use. Participants will additionally receive reminders for insurance renewal, food stamp applications, and health-promoting community events. Participants in this arm will complete a baseline survey when their infant is ≤ 2 months of age, a mid-point survey at 7-9 months, and a follow-up survey at by age 15 months. Receives: Behavioral: Salud al Día |
| Usual Care | No intervention | The participants in the usual care group will receive the clinic's usual care in terms of receiving no text messages. Participants in this arm will complete a baseline survey when their infant is ≤ 2 months of age, a mid-point survey at 7-9 months, and a follow-up survey at by age 15 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Up to Date Well Child Care
Composite variable of % of AAP recommended well visits completed at intervals 12 and 24 months of age, up to date immunizations and screening at 12 and 24 months
Measured: 24 months
Emergency/Urgent Care Utilization
# of ED/Urgent care visits
Measured: 24 months
Parent experience of care
Use of standard measure of healthcare experiences (Child-CAHPS)
Measured: 12 months
Secondary outcomes (5)
Parent activation
Measured: 12 months
Proportion of visits in the the past 12 months with the primary provider
Measured: 12 months
Food stamp enrollment
Measured: 12 months
Continuous health insurance for the child each of the last 12 months
Measured: 12 months
Use of clinic support programs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary Health CareStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation, emocha Mobile Health, Inc., Maryland Institute College of Art
- Responsible party
- Sponsor
- Investigators
- Lisa R DeCamp, MD, MSPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647814
- Sponsor's protocol ID
- IRB00075868
- Status last verified
- Aug 2018
- First submitted
- 18 Dec 2015
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Roseman D, Osborne-Stafsnes J, Amy CH, Boslaugh S, Slate-Miller K. Early lessons from four 'aligning forces for quality' communities bolster the case for patient-centered care. Health Aff (Millwood). 2013 Feb;32(2):232-41. doi: 10.1377/hlthaff.2012.1085.
PubMed 23381515Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.
PubMed 23381511Reuland CJ, Godage SK, Wu L, Valenzuela-Araujo D, Cortez JD, Polk S, DeCamp LR. Information and Communication Technology Access and Use Among Low-Income Latino Immigrant Parents. Matern Child Health J. 2021 Dec;25(12):1807-1813. doi: 10.1007/s10995-021-03265-6. Epub 2021 Oct 23.
PubMed 34687401DeCamp LR, Godage SK, Valenzuela Araujo D, Dominguez Cortez J, Wu L, Psoter KJ, Quintanilla K, Rivera Rodriguez T, Polk S. A Texting Intervention in Latino Families to Reduce ED Use: A Randomized Trial. Pediatrics. 2020 Jan;145(1):e20191405. doi: 10.1542/peds.2019-1405.
PubMed 31879276
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salud al Día: Engaging Latino Parents in Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT02647814
- Acronym / sponsor ID
- IRB00075868
- Conditions
- Primary Health Care
- Keywords
- Parent activation, Text-messages, LEP, Latino populations, pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation, emocha Mobile Health, Inc., Maryland Institute College of Art
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To conduct a pilot randomized controlled trial comparing the effectiveness of a parent support intervention consisting of periodic text messages and educational support (video, collateral materials),and usual care on the healthcare engagement of limited English proficient (LEP) Latino parents during participants' child's first year and to examine its impact on healthcare utilization and primary care quality.
Detailed description
Lessons learned in organizational engagement reveal a critical need to increase healthcare engagement among LEP Latino parents. LEP Latina mothers who were founding members of Latino Family Advisory Board (LFAB) at the Johns Hopkins Bayview Medical Center identified the health system knowledge that enabled participants to more effectively use the healthcare system as one of the key benefits of board membership. The gains in knowledge, skills, and confidence demonstrated in the LFAB evaluation mirror qualitative evaluation findings of other ambulatory care advisory boards, and reflect the concept of patient activation. Patient activation, a component of individual patient engagement, is defined as the patient's willingness to manage their health and healthcare based on understanding one's role in the care process and having the knowledge, skills, and confidence to do so. Interventions focused on increasing activation, using both in-person and mHealth support, have demonstrated efficacy and have led to improvement in health and healthcare quality. mHealth-based interventions have the ability to reach larger populations at lower cost, with the potential for increased tailoring and interactivity, especially as the use of cellular phones becomes nearly universal, even among low-income populations. For example, Text4baby, a perinatal health education program delivered through passive educational text messages, has demonstrated success at reaching low-income Spanish-speaking parents with positive user assessments.
A recent study of parent healthcare activation among low-income parents (conducted by PI: DeCamp) demonstrated that parent activation among parents whose preferred healthcare language was Spanish was significantly lower than that of parents whose preferred healthcare language was English. These findings further support targeting increasing the healthcare engagement of LEP Latino parents.
This novel intervention will integrate mobile health (mHealth) technology and culturally- and linguistically-tailored interpersonal support to increase healthcare engagement of LEP Latino parents and to enable participants to overcome barriers to effective healthcare access and use. Investigators hypothesize that this intervention will measurably increase parent healthcare engagement and that this will positively impact healthcare utilization, quality and the patient/family experience. Increasing healthcare engagement of LEP Latino families and demonstrating positive healthcare impact through a tailored, scalable intervention would create a foundation for larger-scale impact on healthcare disparities for Latino children and a model for increasing engagement of other vulnerable populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salud al Día | Experimental | Behavioral: Salud al DíaThe participants in the intervention group will receive interactive text-messages with a link to support if needed for: clinic appointment reminders, follow-up on medicine and referral adherence, and illness care needs and use. Participants will additionally receive reminders for insurance renewal, food stamp applications, and health-promoting community events. Participants in this arm will complete a baseline survey when their infant is ≤ 2 months of age, a mid-point survey at 7-9 months, and a follow-up survey at by age 15 months. |
| Usual Care | No intervention | –The participants in the usual care group will receive the clinic's usual care in terms of receiving no text messages. Participants in this arm will complete a baseline survey when their infant is ≤ 2 months of age, a mid-point survey at 7-9 months, and a follow-up survey at by age 15 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Parent or legal guardian of a singleton US-born infant ≤ 2 months of age
- Parent or legal guardian age 18 or older
- Parent or legal guardian self-identified as Latino/a
- Parent or legal guardian foreign-born
- Parental report of Spanish as their preferred healthcare language
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salud al DíaA pilot randomized controlled trial comparing the effectiveness of a parent support intervention consisting of periodic text messages and educational support (video, collateral materials),and usual care on the healthcare engagement of LEP Latino parents during their child's first year and to examine its impact on healthcare utilization and primary care quality. | Behavioural | Salud al Día |
Primary outcome
Up to Date Well Child Care
Time frame: 24 months
Composite variable of % of AAP recommended well visits completed at intervals 12 and 24 months of age, up to date immunizations and screening at 12 and 24 months
Emergency/Urgent Care Utilization
Time frame: 24 months
# of ED/Urgent care visits
Parent experience of care
Time frame: 12 months
Use of standard measure of healthcare experiences (Child-CAHPS)
5 secondary outcomes
Parent activation
Time frame: 12 months
Proportion of visits in the the past 12 months with the primary provider
Time frame: 12 months
Food stamp enrollment
Time frame: 12 months
Continuous health insurance for the child each of the last 12 months
Time frame: 12 months
Use of clinic support programs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Background: PubMed 23381515Roseman D, Osborne-Stafsnes J, Amy CH, Boslaugh S, Slate-Miller K. Early lessons from four 'aligning forces for quality' communities bolster the case for patient-centered care. Health Aff (Millwood). 2013 Feb;32(2):232-41. doi: 10.1377/hlthaff.2012.1085.
- Background: PubMed 23381511Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.
- Derived from this study: PubMed 34687401Reuland CJ, Godage SK, Wu L, Valenzuela-Araujo D, Cortez JD, Polk S, DeCamp LR. Information and Communication Technology Access and Use Among Low-Income Latino Immigrant Parents. Matern Child Health J. 2021 Dec;25(12):1807-1813. doi: 10.1007/s10995-021-03265-6. Epub 2021 Oct 23.
- Derived from this study: PubMed 31879276DeCamp LR, Godage SK, Valenzuela Araujo D, Dominguez Cortez J, Wu L, Psoter KJ, Quintanilla K, Rivera Rodriguez T, Polk S. A Texting Intervention in Latino Families to Reduce ED Use: A Randomized Trial. Pediatrics. 2020 Jan;145(1):e20191405. doi: 10.1542/peds.2019-1405.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa R DeCamp, MD, MSPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salud al Día in people with Primary Health Care, run by Johns Hopkins University 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 0 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 16 Aug 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Up to Date Well Child Care (time frame: 24 months). The study lists 3 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 NCT02647814, which also lists 4 linked publications.
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 16 Aug 2018.