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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02233530
Date of registration: 30/08/2014
Prospective Registration: Yes
Primary sponsor: William Keith Gray
Public title: IDEA Study Cognitive Stimulation Therapy (CST) Trial in Nigeria IDEA
Scientific title: Identification and Intervention for Dementia in Elderly Africans (IDEA) Study: CST Trial
Date of first enrolment: September 2014
Target sample size: 8
Recruitment status: Enrolling by invitation
URL:  http://clinicaltrials.gov/show/NCT02233530
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care  
Phase:  N/A
Countries of recruitment
Nigeria
Contacts
Name:     Akin Adebiyi
Address: 
Telephone:
Email:
Affiliation:  University of Ibadan
Name:     Adesola Ogunniyi, MD
Address: 
Telephone:
Email:
Affiliation:  University of Ibadan, Nigeria
Key inclusion & exclusion criteria

Inclusion Criteria:

- Anyone with dementia living within the study site

Exclusion Criteria:

- The participant and the family should have consented to take part in the study.

- Unable to travel to the centre where the CST sessions will be held due to physical
impairment (e.g. bedbound or immobile)

- After assessment by the study doctor, deemed unable to engage in CST sessions (e.g.
follow instructions and participate in activities) due to severe physical or
cognitive impairment.

- Profound deafness

- Total blindness

- Aphasia - they should be able to understand verbal communication and communicate
verbally (mild impairments are acceptable).

- The participant should be able to sit in a group setting for 1 hour.

- There should not be agitation, depression or psychosis to an extent that the person
would not be able to tolerate spending time with other people in a group setting



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Dementia
Intervention(s)
Behavioral: CST intervention
Primary Outcome(s)
World Health Organization brief quality of life measure (WHOQOL-Bref) [Time Frame: An average of eight weeks from baseline]
World Health Organization brief quality of life measure (WHOQOL-Bref) [Time Frame: Baseline]
Secondary Outcome(s)
adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) [Time Frame: An average of eight weeks from baseline]
adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) [Time Frame: An average of twelve weeks from baseline]
adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) [Time Frame: Baseline]
Hospital Anxiety and Depression scale (HADS) [Time Frame: An average of eight weeks from baseline]
Hospital Anxiety and Depression scale (HADS) [Time Frame: An average of twelve weeks from baseline]
Hospital Anxiety and Depression scale (HADS) [Time Frame: Baseline]
IDEA cognitive screen [Time Frame: An average of eight weeks from baseline]
IDEA cognitive screen [Time Frame: An average of twelve weeks from baseline]
IDEA cognitive screen [Time Frame: Baseline]
Study specific economic evaluation [Time Frame: An average of twelve weeks from baseline]
Study specific economic evaluation [Time Frame: Baseline]
WHOQOL Bref [Time Frame: An average of twelve weeks from baseline]
Zarit Burden Interview (ZBI) [Time Frame: An average of eight weeks from baseline]
Zarit Burden Interview (ZBI) [Time Frame: An average of twelve weeks from baseline]
Zarit Burden Interview (ZBI) [Time Frame: Baseline]
Secondary ID(s)
IDEA_NIGERIA_CST1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Grand Challenges Canada
Kilimanjaro Christian Medical Centre, Tanzania
Newcastle University
Northumbria Healthcare NHS Foundation Trust
University of Ibadan
Ethics review
Results
Results available:
Date Posted:
URL:
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