A Study of Brenipatide (LY3537031) Comparing Two Formulations in Healthy Adults
A Phase 1, Open-Label, Randomized, Crossover, Bioequivalence Study to Compare the Pharmacokinetics of Two Different Formulations of Brenipatide (LY3537031) Administered Via Pre-filled Syringe, in Healthy Participants
The SOLE PURPOSE PILOT will be implemented in participating African Methodist Episcopal (AME) churches in Louisiana using a community-based approach that integrates structured education, standardized foot risk assessment, and facilitated clinical referral.
Eligible participants will provide informed consent and complete baseline assessments addressing demographic characteristics, diabetes history, foot health knowledge, self-care practices, perceived risk, and self-efficacy. Participants will undergo a standardized foot risk assessment that may include visual inspection for ulcers, calluses, deformities, and other abnormalities; sensory testing using a monofilament; pedal pulse assessment; ankle-brachial index measurement when indicated; and evaluation of footwear and relevant clinical history. Screening findings will be documented using standardized data collection instruments.
The educational intervention will consist of three interactive sessions delivered over a 4- to 6-week period. Sessions will address: (1) recognition of diabetes-related foot complications and individual risk factors; (2) daily foot self-examination, preventive self-care, and appropriate footwear; and (3) recognition of warning signs requiring prompt medical attention, healthcare navigation, and self-advocacy. Educational activities will incorporate culturally relevant examples, demonstrations, and opportunities for participants to practice foot care skills.
Participants with screening findings indicating the need for additional clinical evaluation will receive facilitated referrals through a coordinated patient navigation process. Referral urgency will be determined by the clinical findings and established referral procedures. Patient navigators will assist with care coordination, appointment scheduling, identification of barriers to care, and follow-up to document referral outcomes.
Participants will be followed for three months after enrollment. Follow-up assessments will document completion of recommended foot evaluations, changes in foot health knowledge and self-care behaviors, self-efficacy, and referral outcomes. Implementation measures will include recruitment and participation, intervention delivery, fidelity to study procedures, participant acceptability, and adoption within participating church settings.
Study data will be collected using standardized instruments and managed according to approved institutional research procedures. Descriptive analyses will characterize participant demographics, baseline foot risk, intervention participation, screening findings, and referral outcomes. Exploratory analyses will examine changes in participant-reported measures and the proportion completing recommended clinical evaluations. Implementation findings will be used to identify operational barriers, facilitators, and considerations for future program refinement and scale-up.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The SOLE PURPOSE PILOT will be implemented in participating African Methodist Episcopal (AME) churches in Louisiana using a community-based approach that integrates structured education, standardized foot risk assessment, and facilitated clinical referral.
Eligible participants will provide informed consent and complete baseline assessments addressing demographic characteristics, diabetes history, foot health knowledge, self-care practices, perceived risk, and self-efficacy. Participants will undergo a standardized foot risk assessment that includes visual inspection for ulcers, calluses, deformities, and other abnormalities; sensory testing using a monofilament; pedal pulse assessment; ankle-brachial index measurement when indicated; and evaluation of footwear and relevant clinical history. Screening findings will be documented using standardized data collection instruments.
The educational intervention will consist of three interactive sessions delivered over a 4- to 6-week period. Sessions will address: (1) recognition of diabetes-related foot complications and individual risk factors; (2) daily foot self-examination, preventive self-care, and appropriate footwear; and (3) recognition of warning signs requiring prompt medical attention, healthcare navigation, and self-advocacy. Educational activities will incorporate culturally relevant examples, demonstrations, and opportunities for participants to practice foot care skills.
Participants with screening findings indicating the need for additional clinical evaluation will receive facilitated referrals through a coordinated patient navigation process. Referral urgency will be determined by the clinical findings and established referral procedures. Patient navigators will assist with care coordination, appointment scheduling, identification of barriers to care, and follow-up to document referral outcomes.
Participants will be followed for three months after enrollment. Follow-up assessments will document completion of recommended foot evaluations, changes in foot health knowledge and self-care behaviors, self-efficacy, and referral outcomes. Implementation measures will include recruitment and participation, intervention delivery, fidelity to study procedures, participant acceptability, and adoption within participating church settings.
Study data will be collected using standardized instruments and managed according to approved institutional research procedures. Descriptive analyses will characterize participant demographics, baseline foot risk, intervention participation, screening findings, and referral outcomes. Exploratory analyses will examine changes in participant-reported measures and the proportion completing recommended clinical evaluations. Implementation findings will be used to identify operational barriers, facilitators, and considerations for future program refinement and scale-up.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Chamika Hawkins-Taylor, PhD, MHA
- Telefonní číslo: 504-520-5363
- E-mail: chawkin5@xula.edu
Studijní záloha kontaktů
- Jméno: Rene' Hymel, DPM, CWS
- Telefonní číslo: 985-400-1295
- E-mail: rene.hymel@ameinhealth.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:Self-identifies as Black or African American. Aged 18 years or older. Has a self-reported or clinically documented diagnosis of diabetes mellitus (Type 1 or Type 2).
Resides in Louisiana or receives healthcare services in Louisiana.
Meets at least one of the following elevated foot-risk criteria:
Previous diabetic foot ulcer or lower extremity amputation. Self-reported symptoms of peripheral neuropathy, including numbness, tingling, or burning sensations in the feet.
Current or recent foot callus, deformity, lesion, or other foot abnormality. Insulin use or diabetes duration of 10 years or longer. Known chronic kidney disease, peripheral artery disease, or previous diabetes-related hospitalization.
Current or recent tobacco smoking. Able and willing to provide informed consent. Willing to participate in the church-based educational intervention, foot risk screening, and follow-up assessments.
Exclusion Criteria:
Younger than 18 years of age. No diagnosis of diabetes mellitus. Does not meet any of the specified elevated foot-risk criteria. Unable to provide informed consent. Unwilling or unable to participate in the study intervention or required follow-up assessments.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Promítání
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: SOLE PURPOSE Foot Health Intervention
Participants assigned to this single-arm intervention will receive a culturally tailored, church-based foot health program delivered over 4-6 weeks. The program includes three structured educational sessions addressing diabetes-related foot complications, preventive foot care, recognition of warning signs, and healthcare navigation. Participants will also receive standardized foot risk screening, including sensory and vascular assessments when indicated, and facilitated referral to appropriate clinical services based on screening findings. Patient navigation will support referral coordination and follow-up. Participants will be assessed for completion of guideline-concordant foot evaluations within three months of enrollment. |
A culturally tailored, church-based intervention integrating structured foot health education, standardized foot risk screening, and facilitated clinical referral for Black adults with diabetes. The intervention includes three interactive educational sessions delivered over 4-6 weeks covering diabetes-related foot complications, daily foot self-examination, preventive care, recognition of warning signs, and healthcare navigation. Participants undergo foot risk screening, including visual inspection, sensory testing, pedal pulse assessment, and ankle-brachial index measurement when indicated. Individuals requiring additional evaluation receive facilitated referrals supported by patient navigation, including care coordination and follow-up to assess completion of recommended foot evaluations. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of Participants Completing a Guideline-Concordant Foot Evaluation
Časové okno: Within 3 months of baseline screening
|
The proportion of enrolled participants who complete a guideline-concordant foot evaluation within three months of baseline screening. A qualifying evaluation includes a podiatry visit, comprehensive primary care diabetic foot examination with documented risk stratification, wound clinic visit, or vascular evaluation when clinically indicated. Completion will be determined through participant self-report, referral tracking logs, and medical record confirmation when available. The outcome will be calculated as the number of participants completing a qualifying evaluation divided by the total number of enrolled participants, expressed as a percentage. |
Within 3 months of baseline screening
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Foot Health Literacy and Knowledge Scores
Časové okno: Baseline, immediately post-intervention, and 3 months after baseline.
|
Change in foot health knowledge will be measured using a study-specific questionnaire assessing recognition of diabetic foot warning signs, appropriate care-seeking, daily foot self-examination, preventive footwear practices, and common misconceptions. Scores will be compared across assessment time points, with higher scores indicating greater knowledge. |
Baseline, immediately post-intervention, and 3 months after baseline.
|
|
Change in Foot Self-Care Behavior Score
Časové okno: Baseline and 3 months after baseline
|
Change in foot self-care behaviors will be assessed using the foot-care subscale of the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire or an equivalent measure. Behaviors assessed include daily foot inspection, appropriate footwear use, avoidance of walking barefoot, and timely reporting of foot problems. Scores will be compared between baseline and three-month follow-up, with higher scores indicating greater adherence to recommended foot self-care practices. |
Baseline and 3 months after baseline
|
|
Proportion of Participants Completing Foot Risk Screening
Časové okno: Baseline (at enrollment)
|
The proportion of enrolled participants who complete a standardized baseline foot risk assessment at a participating church event or linked clinical site. Screening completion will be documented using study assessment records. The measure will be calculated as the number of participants completing the assessment divided by the total number enrolled, expressed as a percentage. |
Baseline (at enrollment)
|
|
Referral Completion Rate Among Participants Requiring Follow-Up
Časové okno: Within 3 months of baseline screening
|
Among participants classified as Tier 2 or Tier 3 based on standardized foot risk screening and referred for additional clinical evaluation, the proportion who complete the recommended evaluation within three months of baseline screening. Referral completion will be assessed using patient navigation records, participant self-report, and clinical documentation when available. The denominator will include all participants receiving a qualifying referral. |
Within 3 months of baseline screening
|
|
Change in Foot Care Self-Efficacy Score
Časové okno: Baseline, immediately post-intervention, and 3 months after baseline
|
Change in participants' confidence in performing daily foot self-examinations, recognizing warning signs, and seeking appropriate professional care will be assessed using study-specific Likert-scale items or a validated self-efficacy instrument. Scores will be compared at baseline, immediately following the educational intervention, and at three-month follow-up. Higher scores will indicate greater confidence in managing foot health. |
Baseline, immediately post-intervention, and 3 months after baseline
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Chamika Hawkins-Taylor, PhD, MHA, Xavier University of Louisiana.
- Vrchní vyšetřovatel: Rene Hymel, DPM, CWSP, Foot Health Center
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 27981
- 001 (Jiné číslo grantu/financování: Louisiana Health Care Connection)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .