NCT07589335

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2026

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

27 days

First QC Date

April 17, 2026

Last Update Submit

May 11, 2026

Conditions

Keywords

Community Health WorkersMenopauseWomen

Outcome Measures

Primary Outcomes (10)

  • Declarative Knowledge Pretest Score

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Secondary Outcomes (1)

  • Satisfaction at posttest

    Upon study completion, average 15 days

Other Outcomes (5)

  • Change in Declarative Knowledge Scores From Pretest to Posttest

    From baseline through study completion, average 15 days

  • Change in Procedural Knowledge Scores From Pretest to Posttest

    From baseline through study completion, average 15 days

  • Change in Skills Scores From Pretest to Posttest

    From baseline through study completion, average 15 days

  • +2 more other outcomes

Study Arms (2)

Treatment: SUPPORT course

EXPERIMENTAL

Lessons 1-4 of professional development training course for CHWs on menopausal transition (SUPPORT)

Other: Lessons 1-4 for SUPPORT course

Control: No SUPPORT course

NO INTERVENTION

No intervention

Interventions

Multi-module SUPPORT online training

Treatment: SUPPORT course

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KDH Research & Communication

Atlanta, Georgia, 30309, United States

Location

Study Officials

  • Morgan Fleming, MPH

    KDH Research & Communication

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2026

First Posted

May 15, 2026

Study Start

March 6, 2026

Primary Completion

April 2, 2026

Study Completion

May 31, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations