Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05262920
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2022-01-11
Brief Title:
Promoting Self-Management of Breast and Nipple Pain With Technology PROMPT for Breastfeeding Women Study
Sponsor:
University of Connecticut
Organization:
University of Connecticut
Study Overview
Official Title:
Promoting Self-Management of Breast and Nipple Pain With Technology PROMPT for Breastfeeding Women Study
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMPT
Brief Summary:
Every year 1 million women cease breastfeeding BF before 6 months the minimum time required for optimal maternal well-being and infants health physical growth and development The highest rate of BF cessation occurs within 3 weeks after birth with 30 of women ceasing BF due to acute breast and nipple pain BNP BNP is a complex and understudied biobehavioral phenomenon involving nociceptive signalling that stimulates multiple pain pathways Women who experience BNP beyond BF initiation report lower BF self-efficacy a key predictor of BF at 6 months increased maternal distress symptoms and may differ across races contributing to differences in early BF cessation rates The investigators developed and tested a 6-week nurse-led and participant-informed Breastfeeding and Breast and Nipple Pain Self-Management BSM intervention guided by the Individual and Family Self-Management Theory Aligned with the needs and preferences elicited from a diverse sample of BF participants the investigators used a cloud-based platform to deliver BF knowledge and skills and provided support through nurse-led text-based communication to decrease BNP increase BF self-efficacy decrease burdensome face-to-face visits and increase adaptive coping behaviors Participants in the BSM intervention group reported significantly reduced BNP intensity at 1 and 2 weeks which predicted increased BF self-efficacy and decreased anxiety at 6 weeks Based on these promising results the investigators propose to examine the efficacy of the BSM intervention in an R56 RCT Promoting Self-Management of Breast and Nipple Pain Using Technology PROMPT for Breastfeeding Women to decrease BNP intensity and interference and increase BF exclusivity The study will reproduce and extend the pilot findings by exploring in a diverse population of BF participants how participants pain sensitivity affects BNP The study will explore the moderating role of BNP and maternal well-being symptoms of fatigue depressive symptoms anxiety and sleep pain pain coping and maternal self-efficacy on BF exclusivity Participants N 222 intending to breastfeed will be randomized to the BSM intervention or the attention control group with assessments performed at baseline 1 2 3 6 9 12 18 and 24 weeks Study results will advance knowledge on the BSM intervention with direct implications for nurse-designed and led self-management interventions in clinical settings or health care systems
Detailed Description:
In response to the critical gap that exists in identifying effective biobehavioral self-management interventions for participants during BF initiation who experience breast and nipple pain BNP the investigators developed a patient-informed Breastfeeding and BNP Self-Management BSM intervention based on the Individual and Family Self-Management Theory The investigators propose to test the effectiveness of the BSM intervention on BNP severity pain interference with daily life and BF outcomes over time in this R56 RCT Promoting Self-Management of Breast and Nipple Pain with Technology PROMPT for Breastfeeding Women Participants N222 intending to BF will be randomized either to receive the BSM intervention or be in the attention control group with assessments performed after birth at the hospital baseline After screening and informed consent participants will be asked to complete study measures undergo quantitative sensory testing using a standardized protocol and access a secure electronic survey site via participants smartphone or study-provided smartphone text links or email before discharge home During the first week home all participants will receive bi-weekly texts with links to BSM intervention BF modules or for the attention control group educational modules on postpartum recovery and infant care All participants at 1 2 3 9 12 and 18 weeks will receive a text or email for ongoing assessments of BNP and BF measures of the exclusivity breast breast milk or formula the number of feedings each day and how long daysweeksmonths infants were breastfed duration In addition the study occurs via mobile technology during an acute period of pain when the rate of BF cessation is the highest At 6- and 24-weeks participants will repeat the study measures and quantitative sensory testing
The PROMPT study is the first to target self-management for BNP using cloud-based educational modules and user-preferred text-based smartphone intervention during the critical weeks of BF initiation when support for BF is most desired face-to-face visits are most burdensome and places the mother-infant dyads at risk for illness such as COVID-19 The study will describe how many participants experience BNP from BF initiation to 24 weeks as participants return to work and who may be at risk for chronic pain which has not been examined The study also replicates and expands on how the presence of pain sensitivity affects BNP and BF outcomes The results from this study hold great promise to 1 support a diverse population of BF participants by identifying the risk factors of BNP 2 target personal interventions for participants experiencing BNP based on unique moderating factors of pain sensitivity nonpharmacological interventions BF self-efficacy pain coping maternal self-efficacy and maternal well-being anxiety depression stress and fatigue and 3 to develop easily accessible strategies for participants BF within clinical settings that allow for large-scale translation in health care systems or public health settings
Participant Recruitment will begin by active and passive methods successfully used in the pilot study with the addition of prenatal recruitment in the clinical site Passive methods include 1 advertisements via Facebook pages Connecticut Breastfeeding Coalition and the School of Nursing Center for the Advancement of Management of Pain CAMP and Instagram ads targeting participants in Connecticut who intend to BF 2 flyers posted at clinical partners offices 3 flyers given by the clinical partners to participants expressing interest in BF during routine prenatal care and referring participants to the peer counselors research assistants or lactation consultants team members on the inpatient hospital units 4 flyers included in discharge educational packets at both recruitment sites 5 flyers posted in hospital HH UConn Health common areas
Active methods include screening the inpatient unit census two to three times per week by the clinical partners for participants who meet inclusion or exclusion criteria Participants who agree to speak with a member of the research team about the study will be approached A HIPAA consent will be obtained for the research team to ask initial screening questions via REDCap Research Electronic Data Capture REDCap is a secure web application and database storage for creating and managing online data collection with highly customizable data types including 21 CFR Part 11 FISMA and HIPAA-compliant environments If eligible informed consent will be obtained by a member of the research team trained in obtaining informed consent and approved by the IRB
The investigators will recruit participants after birth with data collection to occur before discharge from the hospital and take approximately 60 minutes To decrease participant burden recruitment will begin during the antenatal care so participants may anticipate participating in data collection after delivery In BSM pilot study the retention rate was 94 of participants at 6 weeks and as the primary aim is the effectiveness of the intervention during the first 3 weeks the sample size calculations account for the possibility of loss-to-follow-up as high as 5 at 3 weeks Additionally the investigators anticipate the possibility of a 25 attrition rate at 24 weeks a level somewhat larger than the 15-20 rate observed in many longitudinal intervention trials
After informed consent and prior to the start of data collection participants will be randomized to the BSM intervention or the attention control group and be assigned a unique participant identification number Participants will be shown how to access the REDCap modules on participants or a study-provided smartphone An alternative contact persons information will be requested to reduce the likelihood of attrition A randomization schedule created in REDCap will ensure that the two groups remain balanced with respect to age race BF experience antenatal plan for BF duration route of delivery and intent to return to work The randomization assignment will be known to data management graduate assistant with experience in clinical trials intervention monitoring IRB compliance The PI will be blinded to the randomization assignment of participants The graduate assistant will not be involved in data collection but will administer and monitor the interventions and missing data
After discharge both groups will receive an encrypted text via REDCap with embedded links from Twilio a cloud communications platform and a backup archive feature to secure participants privacy and confidentiality from the nurse on the research team The follow-up measures at 1 2 3 9 12 and 18 weeks Figure 4 see research plan include the participants weekly BNP pain coping BF exclusivity ongoing BF assessment BF algorithm and maternal assessment of infant BF behaviors self-efficacy scales pain BF and maternal maternal well-being assessments and perceived well-being scales The completion of the measures will take about 30 minutes Weekly meetings will identify any missing data and contact participants to complete the surveys At 6 and 24 weeks participants will complete the above measures and quantitative sensory testing at the clinical locations The completion of the measures will take about 60 minutes
Intervention Administration Each group will receive a link to the eight video modules that address a different topic within a 15-minute interval During the first week the appropriate link to the first video to the BSM intervention and attention control group will be sent Intervention fidelity will be addressed using continual assessment of design training delivery receipt enactment throughout the study duration Design fidelity is applied through a standardized intervention with scheduled interactive texts text-based daily BF journals and links to modules Dr Lucas will routinely assess the training of the interventionists through simulated scenarios and practice sessions using texting and phone scripts Evidence of treatment will include participants response to bi-weekly texts and targeted lactation support based on galactogenesis and lactation milestones The investigation team will monitor intervention fidelity by using the REDCap feature that allows the study team to view the date time length and the number of times the participant accesses each module and completes the daily BF journal The Project Manager will coordinate the study team to send participants text and follow-up phone calls at 1 2 3 9 12 and 18 weeks at a prescheduled time to encourage completion of the modules and for BSM intervention address any BF concerns After the first week phone calls and encrypted text messages depending on the participant preference will be made by the research team to encourage BF data completion
Participant Retention At enrollment participants will be informed that payment will occur after each data collection point completion and if all data points are completed will receive a study completion bonus To maintain contact and trust the participants in both groups will receive monthly text links at 4 8 12 16 20 and 24 weeks to modules highlighting normal infant development and age-appropriate play
The sample size objective for the study is to recruit N 222 participants who will be randomly assigned to the BSM or attention control study groups at a 11 ratio 111 per group This objective provides 80 percent power α 005 two-sided to detect a standardized mean difference Cohens d of 039 or more between the BSM and attention control groups It also provides 80 percent power to detect an odds ratio of 25 or more in exclusive BF between the two groups assuming that the exclusive BF rate of the control group will be 10 percent higher than the national population rate in 2017 at 6 9 12 18 and 24 weeks These calculations account for loss to follow-up as high as 5 at 3 weeks and 25 at 24 weeks The calculations reflect a conservative approach relative to the attrition rate of 6 that occurred at the 6-week time point in the pilot study and the 15-20 rate observed in many longitudinal intervention trials In the pilot study RM-ANCOVAs with the baseline value of a measure as the covariate revealed standardized mean differences larger than d 039 for the main effect of the intervention on BNP intensity d 045 pain severity d 060 cumulative pain d 064 and BF self-efficacy d 048 cross the 1 2 and 6 week time points For BNP interference the value of d was 039 at week 1 but smaller at weeks 2 and 6 Furthermore the odds of exclusive BF in the intervention group is 29 times higher than the control group at 6 weeks which is also higher than the hypothesized OR 25 Therefore the investigators are confident that the sample size goal will be sufficiently powered to detect intervention effects on key variables for SA1 and SA2
Finally the sample size estimate does not reflect the investigators plans to conduct analyses based on repeated measurement of outcome variables at the 1 2 3 6 9 12 18 and 24 week time points due to the dearth of information regarding 24-week outcomes Generally the inclusion of data for an outcome variable across additional time points marginally enhances statistical power especially for testing main and interaction effects of intervention and time
The PROMPT study is the first to target self-management for BNP using cloud-based educational modules and user-preferred text-based smartphone intervention during the critical weeks of BF initiation when support for BF is most desired face-to-face visits are most burdensome and places the mother-infant dyads at risk for illness such as COVID-19 The study will describe how many participants experience BNP from BF initiation to 24 weeks as participants return to work and who may be at risk for chronic pain which has not been examined The study also replicates and expands on how the presence of pain sensitivity affects BNP and BF outcomes The results from this study hold great promise to 1 support a diverse population of BF participants by identifying the risk factors of BNP 2 target personal interventions for participants experiencing BNP based on unique moderating factors of pain sensitivity nonpharmacological interventions BF self-efficacy pain coping maternal self-efficacy and maternal well-being anxiety depression stress and fatigue and 3 to develop easily accessible strategies for participants BF within clinical settings that allow for large-scale translation in health care systems or public health settings
Participant Recruitment will begin by active and passive methods successfully used in the pilot study with the addition of prenatal recruitment in the clinical site Passive methods include 1 advertisements via Facebook pages Connecticut Breastfeeding Coalition and the School of Nursing Center for the Advancement of Management of Pain CAMP and Instagram ads targeting participants in Connecticut who intend to BF 2 flyers posted at clinical partners offices 3 flyers given by the clinical partners to participants expressing interest in BF during routine prenatal care and referring participants to the peer counselors research assistants or lactation consultants team members on the inpatient hospital units 4 flyers included in discharge educational packets at both recruitment sites 5 flyers posted in hospital HH UConn Health common areas
Active methods include screening the inpatient unit census two to three times per week by the clinical partners for participants who meet inclusion or exclusion criteria Participants who agree to speak with a member of the research team about the study will be approached A HIPAA consent will be obtained for the research team to ask initial screening questions via REDCap Research Electronic Data Capture REDCap is a secure web application and database storage for creating and managing online data collection with highly customizable data types including 21 CFR Part 11 FISMA and HIPAA-compliant environments If eligible informed consent will be obtained by a member of the research team trained in obtaining informed consent and approved by the IRB
The investigators will recruit participants after birth with data collection to occur before discharge from the hospital and take approximately 60 minutes To decrease participant burden recruitment will begin during the antenatal care so participants may anticipate participating in data collection after delivery In BSM pilot study the retention rate was 94 of participants at 6 weeks and as the primary aim is the effectiveness of the intervention during the first 3 weeks the sample size calculations account for the possibility of loss-to-follow-up as high as 5 at 3 weeks Additionally the investigators anticipate the possibility of a 25 attrition rate at 24 weeks a level somewhat larger than the 15-20 rate observed in many longitudinal intervention trials
After informed consent and prior to the start of data collection participants will be randomized to the BSM intervention or the attention control group and be assigned a unique participant identification number Participants will be shown how to access the REDCap modules on participants or a study-provided smartphone An alternative contact persons information will be requested to reduce the likelihood of attrition A randomization schedule created in REDCap will ensure that the two groups remain balanced with respect to age race BF experience antenatal plan for BF duration route of delivery and intent to return to work The randomization assignment will be known to data management graduate assistant with experience in clinical trials intervention monitoring IRB compliance The PI will be blinded to the randomization assignment of participants The graduate assistant will not be involved in data collection but will administer and monitor the interventions and missing data
After discharge both groups will receive an encrypted text via REDCap with embedded links from Twilio a cloud communications platform and a backup archive feature to secure participants privacy and confidentiality from the nurse on the research team The follow-up measures at 1 2 3 9 12 and 18 weeks Figure 4 see research plan include the participants weekly BNP pain coping BF exclusivity ongoing BF assessment BF algorithm and maternal assessment of infant BF behaviors self-efficacy scales pain BF and maternal maternal well-being assessments and perceived well-being scales The completion of the measures will take about 30 minutes Weekly meetings will identify any missing data and contact participants to complete the surveys At 6 and 24 weeks participants will complete the above measures and quantitative sensory testing at the clinical locations The completion of the measures will take about 60 minutes
Intervention Administration Each group will receive a link to the eight video modules that address a different topic within a 15-minute interval During the first week the appropriate link to the first video to the BSM intervention and attention control group will be sent Intervention fidelity will be addressed using continual assessment of design training delivery receipt enactment throughout the study duration Design fidelity is applied through a standardized intervention with scheduled interactive texts text-based daily BF journals and links to modules Dr Lucas will routinely assess the training of the interventionists through simulated scenarios and practice sessions using texting and phone scripts Evidence of treatment will include participants response to bi-weekly texts and targeted lactation support based on galactogenesis and lactation milestones The investigation team will monitor intervention fidelity by using the REDCap feature that allows the study team to view the date time length and the number of times the participant accesses each module and completes the daily BF journal The Project Manager will coordinate the study team to send participants text and follow-up phone calls at 1 2 3 9 12 and 18 weeks at a prescheduled time to encourage completion of the modules and for BSM intervention address any BF concerns After the first week phone calls and encrypted text messages depending on the participant preference will be made by the research team to encourage BF data completion
Participant Retention At enrollment participants will be informed that payment will occur after each data collection point completion and if all data points are completed will receive a study completion bonus To maintain contact and trust the participants in both groups will receive monthly text links at 4 8 12 16 20 and 24 weeks to modules highlighting normal infant development and age-appropriate play
The sample size objective for the study is to recruit N 222 participants who will be randomly assigned to the BSM or attention control study groups at a 11 ratio 111 per group This objective provides 80 percent power α 005 two-sided to detect a standardized mean difference Cohens d of 039 or more between the BSM and attention control groups It also provides 80 percent power to detect an odds ratio of 25 or more in exclusive BF between the two groups assuming that the exclusive BF rate of the control group will be 10 percent higher than the national population rate in 2017 at 6 9 12 18 and 24 weeks These calculations account for loss to follow-up as high as 5 at 3 weeks and 25 at 24 weeks The calculations reflect a conservative approach relative to the attrition rate of 6 that occurred at the 6-week time point in the pilot study and the 15-20 rate observed in many longitudinal intervention trials In the pilot study RM-ANCOVAs with the baseline value of a measure as the covariate revealed standardized mean differences larger than d 039 for the main effect of the intervention on BNP intensity d 045 pain severity d 060 cumulative pain d 064 and BF self-efficacy d 048 cross the 1 2 and 6 week time points For BNP interference the value of d was 039 at week 1 but smaller at weeks 2 and 6 Furthermore the odds of exclusive BF in the intervention group is 29 times higher than the control group at 6 weeks which is also higher than the hypothesized OR 25 Therefore the investigators are confident that the sample size goal will be sufficiently powered to detect intervention effects on key variables for SA1 and SA2
Finally the sample size estimate does not reflect the investigators plans to conduct analyses based on repeated measurement of outcome variables at the 1 2 3 6 9 12 18 and 24 week time points due to the dearth of information regarding 24-week outcomes Generally the inclusion of data for an outcome variable across additional time points marginally enhances statistical power especially for testing main and interaction effects of intervention and time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R56NR020041 | NIH | None | httpsreporternihgovquickSearchR56NR020041 |