Supplying Useful Perimenopause Through Post-menopause Online Resources and Tools (SUPPORT)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The investigators will use a randomized, two-group, pretest/posttest design to develop and evaluate the Supplying Useful Perimenopause through Post-menopause Online Resources and Tools (SUPPORT) course and explore the following research question: To what extent does exposure to the SUPPORT prototype increase community health workers' (CHWs) knowledge, skills, and self-efficacy to conduct mental health outreach to minority women experiencing the menopausal transition?
The SUPPORT prototype will have four lessons with text, video vignettes, handouts, and artificial intelligence (AI) avatar simulations. CHWs assigned to the treatment group will be exposed to SUPPORT prototype before completing the posttest while CHWs assigned to the control group will be exposed to the SUPPORT prototype after completing the posttest.
Researchers worked with subject matter experts and the intended audience to ensure the SUPPORT course includes accurate material and reflects the specific needs of CHWs providing outreach to women experiencing the menopausal transition.
Co-Principal Investigators Morgan Fleming (KDH Research & Communication), with input from Co-PI Mary Dolan (Emory University) and the subject matter experts, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials. Co-PI Fleming also outlined the appropriate statistical analysis methods. All procedure documents will be reviewed by the KDH Research & Communication (KDHRC) Institutional Review Board before the evaluation launch.
Investigators will recruit participants by sharing the opportunity through the KDHRC CHW panel, which notifies more than 700 subscribed CHWs about research opportunities. Notifications and flyers will provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.
The study will include up to 160 CHWs nationwide (80 treatment group, 80 control group). KDHRC will remind participants that participation in the study is completely voluntary.
Investigators will confirm consent for each participant and after confirming consent, will send participants the link to complete the pretest survey. Once the investigators receive the pretest survey, they will randomize each participant into the treatment group or control group using a 1:1 randomization. Investigators will alternate assigning each participant with completed pretest to the treatment groups or the control groups. Then, investigators will provide each participant with group-specific information. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.
The investigators will download and export the data from the online survey platform into encrypted Excel files and import the raw data into STATA. The investigators will match the pretest and posttest using the non-personal identifiers and conduct analyses to test for the effect of SUPPORT course exposure on changes in CHWs' knowledge, skills, and self-efficacy.
The initial evaluation criterion is: Statistically significant (p<0.05) and positive relationship between exposure to SUPPORT course and increased knowledge among the treatment group in comparison to the control group.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30309
- KDH Research & Communication
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Must be at least 18 years old.
- Must self-identify as a community health worker (CHW).
- Must live in the United States.
- Must conduct outreach to minority women.
- Must have six months of field experience. KDHRC defines "field experience" as conducting outreach activities in their community, for example, working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events.
- Must be an active CHW. KDHRC defines "active" as conducting outreach activities, such as working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events, in the last six months.
- Must have Internet access either at home or at work to access the materials and/or online surveys
Exclusion Criteria:
- none
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Treatment: SUPPORT course
Lessons 1-4 of professional development training course for CHWs on menopausal transition (SUPPORT)
|
Multi-module SUPPORT online training
|
|
Ingen inngripen: Control: No SUPPORT course
No intervention
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Declarative Knowledge Pretest Score
Tidsramme: Baseline
|
Investigators will ask participants multiple-choice knowledge questions related to the menopausal transition, which the investigators will sum to create a composite knowledge score ranging from 0 to 7. A score of 0 means a participant got zero questions correct, while a score of 7 means a participant got all 7 questions correct.
Then, the investigators will create the composite knowledge average by dividing the participant's composite score by the total number of questions (7) and multiplying by 100.
The higher the score, the more questions a participant answered correctly.
|
Baseline
|
|
Declarative Knowledge Posttest Score
Tidsramme: Upon study completion, average 15 days
|
Investigators will ask participants multiple-choice knowledge questions related to the menopausal transition, which the investigators will sum to create a composite knowledge score ranging from 0 to 7. A score of 0 means a participant got zero questions correct, while a score of 7 means a participant got all 7 questions correct.
Then, the investigators will create the composite knowledge average by dividing the participant's composite score by the total number of questions (7) and multiplying by 100.
The higher the score, the more questions a participant answered correctly.
|
Upon study completion, average 15 days
|
|
Procedural Knowledge Pretest Score
Tidsramme: Baseline
|
Investigators will ask participants multiple-choice procedural knowledge questions related to the menopausal transition, which the investigators will sum to create a composite procedural knowledge score ranging from 0 to 5. A score of 0 means a participant got zero questions correct, while a score of 5 means a participant got all 5 questions correct.
Then, investigators will create the composite procedural knowledge average by dividing the participant's composite score by the total number of questions (5) and multiplying by 100.
The higher the score, the more questions a participant answered correctly.
|
Baseline
|
|
Procedural Knowledge Posttest Score
Tidsramme: Upon study completion, average 15 days
|
Investigators will ask participants multiple-choice procedural knowledge questions related to the menopausal transition, which investigators will sum to create a composite procedural knowledge score ranging from 0 to 5. A score of 0 means a participant got zero questions correct, while a score of 5 means a participant got all 5 questions correct.
Then, investigators will create the composite procedural knowledge average by dividing the participant's composite score by the total number of questions (5) and multiplying by 100.
The higher the score, the more questions a participant answered correctly.
|
Upon study completion, average 15 days
|
|
Skills Pretest Score
Tidsramme: Baseline
|
Investigators will ask all participants Likert-type scale questions about skills to conduct menopausal transition outreach.
Each answer choice rating will range from 1 to 10, with higher ratings representing more outreach experience.
Investigators will create the composite skills score by summing the scores from the participant's 15 skill items with a range of 15 to 150.
Then, investigators will create the composite skills average by dividing the participant's composite score by the total number of questions (15), and the composite score will range from 1 to 10.
The higher the score, the more experience a participant indicates.
|
Baseline
|
|
Skills Posttest Score
Tidsramme: Upon study completion, average 15 days
|
Investigators will ask all participants Likert-type scale questions about skills to conduct menopausal transition outreach.
Each answer choice rating will range from 1 to 10, with higher ratings representing more outreach experience.
Investigators will create the composite skills score by summing the scores from the participant's 15 skill items with a range of 5 to 150.
Then, Investigators will create the composite skills average by dividing the participant's composite score by the total number of questions (15), and the composite score will range from 1 to 10.
The higher the score, the more experience a participant indicates.
|
Upon study completion, average 15 days
|
|
Self-efficacy Pretest Score
Tidsramme: Baseline
|
Investigators will ask all participants Likert-type scale questions related to perceived self-efficacy with conducting menopausal transition outreach.
Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in providing outreach.
Investigators will create the composite self-efficacy score by summing the scores from the participant's 5 self-efficacy items with a range of 5 to 50.
Then, investigators will create the composite self-efficacy average by dividing the participant's composite score by the number of self-efficacy items (5).
The composite will range from 1 to 10.
|
Baseline
|
|
Self-efficacy Posttest Score
Tidsramme: Upon study completion, average 15 days
|
Investigators will ask all participants Likert-type scale questions related to perceived self-efficacy with conducting menopausal transition outreach.
Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in providing outreach.
Investigators will create the composite self-efficacy score by summing the scores from the participant's 5 self-efficacy items with a range of 5 to 50.
Then, investigators will create the composite self-efficacy average by dividing the participant's composite score by the number of self-efficacy items (5).
The composite average will range from 1 to 10.
|
Upon study completion, average 15 days
|
|
Intentions Pretest Score
Tidsramme: Baseline
|
Investigators will ask all participants Likert-type scale questions related to intentions of conducting menopausal transition outreach.
Each rating will range from 1 to 10, with higher ratings representing higher intentions to provide outreach.
Investigators will create the composite intention score by summing the scores from the participant's 4 intention items with a range of 4 to 40.
Then, investigators will create the composite intentions average by dividing the participant's composite score by the number of intention items (4).
The composite average will range from 1 to 10.
|
Baseline
|
|
Intentions Posttest Score
Tidsramme: Upon study completion, average 15 days
|
Investigators will ask all participants Likert-type scale questions related to intentions of conducting menopausal transition outreach.
Each rating will range from 1 to 10, with higher ratings representing higher intentions to provide outreach.
Investigators will create the composite intention score by summing the scores from the participant's 4 intentions items with a range of 4 to 40.
Then, investigators will create the composite intention average by dividing the participant's composite score by the number of intention items (4).
The composite average will range from 1 to 10.
|
Upon study completion, average 15 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Satisfaction at posttest
Tidsramme: Upon study completion, average 15 days
|
Investigators will ask only the treatment group participants Likert-type scale questions related to their satisfaction with the SUPPORT course.
Each rating will range from 1 to 10, with higher scores representing higher satisfaction with the SUPPORT prototype.
Investigators will sum the scores from the participant's 4 satisfaction items for a satisfaction composite score ranging from 4 to 40.
Investigators will then create the satisfaction composite average by dividing by the total number of satisfaction items (4).
Scores range from 1 to 10, with higher scores meaning better satisfaction/outcome.
|
Upon study completion, average 15 days
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Declarative Knowledge Scores From Pretest to Posttest
Tidsramme: From baseline through study completion, average 15 days
|
At both pretest and posttest, investigators created a composite knowledge score for each participant ranging from 0 to 100.
A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct.
Investigators will then subtract pretest composite from posttest composite.
Higher scores mean higher gains from baseline to posttest.
|
From baseline through study completion, average 15 days
|
|
Change in Procedural Knowledge Scores From Pretest to Posttest
Tidsramme: From baseline through study completion, average 15 days
|
At both pretest and posttest, investigators created a composite procedural knowledge score for each participant ranging from 0 to 100.
A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct.
Investigators will then subtract pretest composite from posttest composite.
Higher scores mean higher gains from baseline to posttest.
|
From baseline through study completion, average 15 days
|
|
Change in Skills Scores From Pretest to Posttest
Tidsramme: From baseline through study completion, average 15 days
|
At both pretest and posttest, investigators created a composite skills score for each participant ranging from 1 to 10. Higher ratings represent higher perceived experience.
Investigators will then subtract pretest composite from posttest composite.
Higher scores mean higher gains from baseline to posttest.
|
From baseline through study completion, average 15 days
|
|
Change in Self-efficacy Scores From Pretest to Posttest
Tidsramme: From baseline through study completion, average 15 days
|
At both pretest and posttest, investigators created a composite self-efficacy score for each participant ranging from 1 to 10. Higher ratings represent high perceptions of confidence in providing outreach.
Investigators will then subtract pretest composite from posttest composite.
Higher scores mean higher gains from baseline to posttest.
|
From baseline through study completion, average 15 days
|
|
Change in Intentions Scores From Pretest to Posttest
Tidsramme: From baseline through study completion, average 15 days
|
At both pretest and posttest, investigators created a composite intentions score for each participant ranging from 1 to 10. Higher ratings represent high intentions in providing outreach.
Investigators will then subtract pretest composite from posttest composite.
Higher scores mean higher gains from baseline to posttest.
|
From baseline through study completion, average 15 days
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Morgan Fleming, MPH, KDH Research & Communication
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2025-05-07
- 1R43MD018555-01A1 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .