NCT07180719

Brief Summary

Stigma underlies many health disparities in Kenya, and dementia-related stigma is no different. Preliminary evidence highlights the short-term benefits of a dementia anti-stigma intervention in Kenya. The study aims to ascertain the long-term effectiveness of a locally developed dementia anti stigma intervention in order to establish a community resource that will improve dementia understanding, reduce stigma and improve health behaviours. In AIM 1, the investigators will assess what public stigma towards people with dementia and their carers looks like in Kenya, through a survey (600). Individual interviews with 20 members of the general public who completed the survey will be conducted to explore what stigmatizing beliefs are held and why they form. Triangulation techniques will then be used to integrate quantitative and qualitative data. Reflecting on AIM 1 findings, the investigators will engage 20 key stakeholders to refine an existing anti-stigma intervention, to better target culturally specific misconceptions and negative beliefs about dementia (AIM2). In AIM 3, the investigators will determine the effectiveness of the intervention among members of the general public (n=184), through a stepped wedge cluster randomized trial (SWT).

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Sep 2025

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Sep 2025Jun 2027

First Submitted

Initial submission to the registry

September 5, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

September 8, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2027

Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

September 5, 2025

Last Update Submit

September 11, 2025

Conditions

Keywords

DementiaAnti stigmaInterventionStepped Wedge Cluster Randomized Trial

Outcome Measures

Primary Outcomes (2)

  • Change in Dementia attitudes (measured by the Dementia Attitudes Scale (DAS))

    Dementia attitudes will be assessed using the Dementia Attitudes Scale (DAS), a validated tool that measures participants' comfort and perceptions when interacting with people with dementia. Scores on the DAS range from 20 to 140, with higher scores indicating more positive attitudes.

    Assessments will be collected at baseline during enrollment of participants, then every 3 months up until 6 months after switch points of the intervention.

  • Change in Dementia knowledge (measured by the Dementia Knowledge Assessment Scale (DKAS))

    Dementia knowledge will be assessed using the Dementia Knowledge Assessment Scale (DKAS), which evaluates knowledge across domains such as causes, symptoms, risk factors, and care of people with dementia. Scores on the DKAS range from 0 to 50, with higher scores reflecting greater knowledge.

    Assessments will be collected at baseline during enrollment of participants, then every 3 months up until 6 months after switch points of the intervention.

Secondary Outcomes (2)

  • Intervention acceptability

    Immediately post-intervention (within 2 weeks after completion of the 4-session program).

  • Change in Dementia engagement (Behavior)

    From baseline during enrollment of participants, then every 3 months up until 6 months after switch points of the intervention.

Study Arms (2)

Control (Pre-Intervention Phase)

NO INTERVENTION

Participants are assessed before they receive the dementia anti-stigma intervention. They continue with usual community experiences and do not receive any intervention activities during this time. Outcomes collected reflect baseline knowledge and attitudes related to dementia in the absence of the intervention.

Post-Intervention Phase

OTHER

Participants are assessed after receiving the dementia anti-stigma intervention, which consists of four structured sessions facilitated by trained community health promoters (CHPs). The sessions focus on improving dementia knowledge, reducing stigma, and promoting supportive attitudes toward people with dementia and their families. Outcomes collected reflect changes in dementia knowledge and attitudes following the intervention.

Behavioral: Dementia anti stigma intervention

Interventions

The intervention is a train-a-trainer programme contextually developed, for delivery (via demonstrations and role-plays) by lay providers such as community health workers. It includes four sessions that promote: (i) understanding of dementia, (ii) demystifying myths and misconceptions, (iii) empathetic connections using videos of people with dementia and carers (virtual social contact) and (iv) social inclusion through a case vignette and discussions. It is delivered bi-weekly in a group setting and each session ranges between 1.5 to 2 hours.

Post-Intervention Phase

Eligibility Criteria

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

You may qualify if:

  • Residents of Mbooni Sub county
  • Aged 18 years and above
  • Able to speak the local language (Kamba)
  • Have capacity to consent

You may not qualify if:

  • Non residents of Mbooni Sub county
  • Less than 18 years
  • Do not speak the local language
  • Have no capacity to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Christine Musyimi, PhD

    Africa Institute of Mental and Brain Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Musyimi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Randomization to receive the intervention will be conducted by a blinded independent researcher.
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 18, 2025

Study Start

September 8, 2025

Primary Completion (Estimated)

June 28, 2027

Study Completion (Estimated)

June 28, 2027

Last Updated

September 18, 2025

Record last verified: 2025-09