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Completed

NCT Number: NCT07589335

Supplying Useful Perimenopause Through Post-menopause Online Resources and Tools

The goal of the study is to examine the extent to which exposure to the SUPPORT prototype increases community health workers' (CHWs) knowledge, skills, and self-efficacy to conduct effective outreach to minority women experiencing the menopausal transition. The investigators will collect quantitative, pretest and posttest survey data from adult CHWs.

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Key information

Conditions

Women African Americans Community Health Workers Health Hispanic or Latino Menopause

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KDH Research & Communication

Atlanta, Georgia, 30309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lessons 1-4 for SUPPORT course

Other

Multi-module SUPPORT online training

Primary outcomes

  1. Declarative Knowledge Pretest Score

    Time frame: 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.

  2. Declarative Knowledge Posttest Score

    Time frame: 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.

  3. Procedural Knowledge Pretest Score

    Time frame: 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.

  4. Procedural Knowledge Posttest Score

    Time frame: 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.

  5. Skills Pretest Score

    Time frame: 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.

  6. Skills Posttest Score

    Time frame: 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.

  7. Self-efficacy Pretest Score

    Time frame: 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.

  8. Self-efficacy Posttest Score

    Time frame: 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.

  9. Intentions Pretest Score

    Time frame: 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.

  10. Intentions Posttest Score

    Time frame: 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.

Secondary outcomes

  1. Satisfaction at posttest

    Time frame: 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.

Other outcomes

  1. Change in Declarative Knowledge Scores From Pretest to Posttest

    Time frame: 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.

  2. Change in Procedural Knowledge Scores From Pretest to Posttest

    Time frame: 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.

  3. Change in Skills Scores From Pretest to Posttest

    Time frame: 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.

  4. Change in Self-efficacy Scores From Pretest to Posttest

    Time frame: 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.

  5. Change in Intentions Scores From Pretest to Posttest

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

KDH Research & Communication

Industry

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: SUPPORT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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