Text Messaging vs In-Person Counseling for Maternal Health

Recruiting at 1 trial location

Overseen By Janna Garcia Torres

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Psychiatric, Developmental disability

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

900 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on lifestyle counseling, so it's unlikely that medication changes are required, but you should confirm with the trial organizers.

What data supports the effectiveness of the treatment High Touch - Community Health Worker (CHW) Implementation Strategy and Low Touch - Text Messaging Implementation Strategy for maternal health?

Research shows that mobile health (mHealth) tools, like text messaging and smartphone applications, can improve communication, efficiency, and data management for community health workers (CHWs), which may enhance the quality of care and support for maternal health. However, the effectiveness of text-message reminders alone was limited in improving health worker performance in managing diseases in Malawi, suggesting that combining mHealth with CHW strategies might be more beneficial. ^{1 2 3 4 5}

Is text messaging for maternal health counseling safe for humans?

The research on using mobile phones and text messaging for health interventions, including those led by community health workers, suggests that these methods are generally safe. However, the studies primarily focus on effectiveness and implementation rather than direct safety concerns. ^{1 3 5 6 7}

How is the Text Messaging vs In-Person Counseling treatment for maternal health unique?

This treatment is unique because it uses mobile phone text messaging to support community health workers in providing maternal health services, offering a low-cost and accessible way to enhance patient engagement and service delivery, especially in low-resource settings. ^{1 3 8 9 10}

What is the purpose of this trial?

The study will apply the principles of Community Based Participatory Research to evaluate implementation strategies, designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants. The primary strategies include a technology supported strategy (low touch) in which text messaging and online videos are used for asynchronous viewing compared to a Community Health Worker-led synchronous (group and individual) strategy (high touch). Prior to implementation, one-time interview and focus groups will be conducted with clinic providers and staff. In addition, a subsample of subjects will be enrolled into a prospective cohort to complete a survey during pregnancy and a survey postpartum. The aims of the study are 1) to evaluate and compare adoption of the program delivery with text technology messaging vs. delivery by Community Health Workers (CHW), 2) to examine implementation fidelity , 3) to evaluate and compare the impact of the strategies on key clinical outcomes, 4) to examine sustainability (continued adoption) following the CHW-led strategy implementation period and conduct an economic evaluation of the two-implementation strategies.

Research Team

Natasha Williams, EdD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for pregnant individuals who can participate in lifestyle counseling to improve maternal health. It's not clear what specific conditions exclude someone from participating, but typically, trials require participants to be over a certain age and have the ability to give informed consent.

Inclusion Criteria

Confirmed pregnant and <20 weeks 0 days gestational age

receiving care at one of the 10 clinics

able to speak and read English or Spanish

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of lifestyle counseling intervention using technology-supported and Community Health Worker-led strategies

12 months

Asynchronous and synchronous sessions

Follow-up

Participants are monitored for adherence, pre-term delivery, and other outcomes postpartum

12 weeks postpartum

Postpartum follow-up visits

Sustainability Evaluation

Evaluation of continued adoption and economic evaluation of implementation strategies

Up to 5 years

Treatment Details

Interventions

• High Touch - Community Health Worker (CHW) Implementation Strategy
• Low Touch - Text Messaging Implementation Strategy

Trial Overview The RESTORE Phase II study is testing two ways of delivering lifestyle advice during pregnancy: one uses text messages and online videos (low touch), while the other involves personal guidance from Community Health Workers (high touch). The study will compare how well each method works and their effects on clinical outcomes.

Participant Groups

Group I: Community Health Worker (High Touch Group) Experimental Treatment 1 Intervention

During the intervention period (high touch) asynchronous and synchronous learning whereby content will be delivered by trained M-CHWs who are equipped to directly address social determinants of health-related needs and barriers to prenatal care.

Group II: Technology supported (Low Touch) Strategy Active Control 1 Intervention

During the control period (low touch), asynchronous videos summarizing healthy lifestyle content will be delivered via text messaging.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Text-message reminders for health workers (HWs) were well-received and appreciated as helpful job aids, but did not significantly improve adherence to case management guidelines due to systemic barriers like high workloads and stock-outs.

The study suggests that while SMS reminders can enhance understanding of treatment guidelines, additional support such as targeted supervision and two-way communication may be necessary to overcome structural challenges and improve clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mobile phone text message reminders on health workers' adherence to case management guidelines for malaria and other diseases in Malawi: lessons from qualitative data from a cluster-randomized trial. Kaunda-Khangamwa, BN., Steinhardt, LC., Rowe, AK., et al.[2020]

In a study conducted in Singida, Tanzania, community health workers (CHWs) trained to use a smartphone application reported improved quality of care and communication during prenatal counseling visits, highlighting the positive impact of mobile health (mHealth) tools on service delivery.

Clients and supervisors perceived smartphone-assisted counseling as a sign of modern healthcare, which enhanced their expectations of health services, suggesting that integrating mHealth into health systems can lead to better maternal and newborn health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'It makes you someone who changes with the times': health worker and client perspectives on a smartphone-based counselling application deployed in rural Tanzania. Hackett, K., Kazemi, M., Lafleur, C., et al.[2020]

The mobile job aid developed for community health workers (CHWs) in Dar es Salaam, Tanzania, was found to be highly acceptable by both CHWs and clients, enhancing the quality of family planning services by providing timely and convenient care.

CHWs reported improvements in service quality, including better information and increased method choice for clients, although challenges remain in ensuring that clients are informed about all available contraceptive options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of a family planning mobile job aid for community health workers in Tanzania. Braun, R., Lasway, C., Agarwal, S., et al.[2018]

Mobile phones significantly empower community health workers (CHWs) by enhancing their influence and status, which can lead to improved community health outcomes.

The advancement of mobile health (mHealth) applications is expected to primarily occur through a 'diffusion of innovation' process rather than solely through formal intervention research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell phones and CHWs: a transformational marriage? [2021]

Community health workers (CHWs) significantly improve population health by connecting individuals to necessary resources, and integrating mobile health (mHealth) tools can enhance their effectiveness, as shown in a review of 64 studies published between 2007 and 2018.

Despite the positive impact of mHealth interventions involving CHWs, challenges remain, including a lack of culturally relevant tools, inconsistent methodologies for assessing outcomes, and the need for better training and communication among health care teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Mobile Health (mHealth) Technologies and Interventions Among Community Health Workers Globally: A Scoping Review. Early, J., Gonzalez, C., Gordon-Dseagu, V., et al.[2020]

Mobile phone-based information systems can enhance the management and supervision of community health workers (CHWs), as demonstrated in two Randomized Controlled Trials in South Africa.

These systems allow CHWs to initiate intervention visits and receive real-time support from supervisors, potentially improving the quality of health interventions, although the actual impact on community health outcomes still needs further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of a mobile information system to improve quality of care by community health workers. Tomlinson, M., Rotheram-Borus, MJ., Doherty, T., et al.[2022]

Community Health Workers found mobile phone-based text messaging to be a feasible and effective tool for collecting and reporting data on Lymphatic Filariasis morbidity, enhancing their performance and efficiency.

The use of mobile technology significantly reduced paperwork, increased patient access to healthcare services, and allowed for real-time reporting, demonstrating its potential to improve health systems in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The viability of utilising phone-based text messages in data capture and reporting morbidities due to lymphatic Filariasis by community health workers: a qualitative study in Kilwa district, Tanzania. Kalinga, A., Munga, M., Ngenya, A., et al.[2022]

A study conducted in 100 health centers in north-western China found that mobile phone text messaging significantly improved health workers' knowledge of clinical recommendations compared to traditional training methods, with knowledge scores increasing in the text messaging group but not in the control group.

The use of text messaging also led to a decrease in steroid prescriptions by 5 percentage points among health workers, while the control group saw an increase in both antibiotic and steroid prescriptions, highlighting the potential of text messaging to positively influence prescribing behavior in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of text messages to communicate clinical recommendations to health workers in rural China: a cluster-randomized trial. Chen, Y., Yang, K., Jing, T., et al.[2022]

A user-centered design thinking approach was successfully used to create a two-way SMS text messaging tool that enhances communication between patients with chronic conditions and community health workers, based on feedback from 127 patients and caregivers.

The final tool evolved from a basic template to a dynamic and personalized system that addresses individual patient needs, including social factors like transportation and appointment reminders, making it more effective for patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Two-Way Interactive Text Messaging Application for Low-Income Patients with Chronic Medical Conditions: Design-Thinking Development Approach. Marko-Holguin, M., Cordel, SL., Van Voorhees, BW., et al.[2020]

In a study involving 66 low-literate traditional midwives and 15 high-literate certified midwives in Liberia, SMS technology was found to be more successfully utilized by certified midwives, highlighting the importance of literacy in data transmission accuracy.

The study revealed that traditional midwives had a significantly higher error rate in SMS reporting compared to certified midwives, suggesting that SMS interventions should be tailored for health care workers with higher literacy levels to improve data collection efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Texting From the Bush: Data Collection Using SMS Text Messaging in Areas of Low Network Coverage From Low-Literacy Providers. Perosky, JE., Munro, ML., Kay, JL., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of mobile phone text message reminders on health workers' adherence to case management guidelines for malaria and other diseases in Malawi: lessons from qualitative data from a cluster-randomized trial. [2020]

2. England pubmed.ncbi.nlm.nih.gov

'It makes you someone who changes with the times': health worker and client perspectives on a smartphone-based counselling application deployed in rural Tanzania. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

An evaluation of a family planning mobile job aid for community health workers in Tanzania. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Cell phones and CHWs: a transformational marriage? [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Use of Mobile Health (mHealth) Technologies and Interventions Among Community Health Workers Globally: A Scoping Review. [2020]

6. South Africa pubmed.ncbi.nlm.nih.gov

Value of a mobile information system to improve quality of care by community health workers. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The viability of utilising phone-based text messages in data capture and reporting morbidities due to lymphatic Filariasis by community health workers: a qualitative study in Kilwa district, Tanzania. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Use of text messages to communicate clinical recommendations to health workers in rural China: a cluster-randomized trial. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

A Two-Way Interactive Text Messaging Application for Low-Income Patients with Chronic Medical Conditions: Design-Thinking Development Approach. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Texting From the Bush: Data Collection Using SMS Text Messaging in Areas of Low Network Coverage From Low-Literacy Providers. [2022]