IDEA Study Cognitive Stimulation Therapy (CST) Trial in Nigeria

NCT02233530 | Completed Results DMC

• 1 other identifier: IDEA_NIGERIA_CST1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This trials of cognitive stimulation therapy (CST) in Tanzania is part of the larger Identification and Intervention for Dementia in Elderly Africans (IDEA) study. The overall aim of the IDEA study is to set up and evaluate sustainable programmes to facilitate diagnosis of, and therapy for, people with dementia led by local communities in sub-Saharan Africa. The investigators seek to improve quality of life for people with dementia and their caregivers. Within this trial of CST, the investigators hypothesise that CST can significantly improve the quality of people with dementia and their carers living in Africa

Conditions

Dementia

Keywords

Dementia; Cognitive Stimulation Therapy; Quality of life; Cognitive impairment; Africa; Tanzania; Nigeria; Low- and Middle-income countries; Non-pharmacological intervention; Task-shifting; Cognitive screening

Outcome Measures

Primary Outcomes (2)

• World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)

  Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.

  Baseline

• World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)

  Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.

  An average of eight weeks from baseline

Secondary Outcomes (15)

• WHOQOL Bref

  An average of twelve weeks from baseline

• IDEA Cognitive Screen

  Baseline

• IDEA Cognitive Screen

  An average of eight weeks from baseline

• IDEA Cognitive Screen

  An average of twelve weeks from baseline

• Hospital Anxiety and Depression Scale (HADS)

  Baseline

Study Arms (1)

CST intervention

EXPERIMENTAL

Outcomes at baseline will be compared with those immediately post intervention and at four weeks post-intervention. In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. The investigators will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location. Individuals will be allocated to groups based on religion, gender and geographical location.

Behavioral: CST intervention

Interventions

CST intervention BEHAVIORAL

The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life. Sessions will be led and facilitated by a study nurse or occupational therapist. The sessions will be held at a local health centre of village hall.

CST intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Anyone with dementia living within the study site

You may not qualify if:

• 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

Sponsors & Collaborators

• William Keith Gray: lead
• Grand Challenges Canada: collaborator
• University of Ibadan: collaborator
• Kilimanjaro Christian Medical Centre, Tanzania: collaborator
• Newcastle University: collaborator
• Northumbria Healthcare NHS Foundation Trust: collaborator

Study Sites (1)

Lalupon

Lalupon, Oyo State, Nigeria

Location

Related Publications (1)

• Gray WK, Paddick SM, Kisoli A, Dotchin CL, Longdon AR, Chaote P, Samuel M, Jusabani AM, Walker RW. Development and Validation of the Identification and Intervention for Dementia in Elderly Africans (IDEA) Study Dementia Screening Instrument. J Geriatr Psychiatry Neurol. 2014 Jun;27(2):110-8. doi: 10.1177/0891988714522695. Epub 2014 Feb 26.

  PMID: 24578459 BACKGROUND

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Dr Adesola Ogunniyi
• Organization: University of Ibadan, Ibadan, Nigeria

aogunniyi892@gmail.com

+2348038094173

Study Officials

• Adesola Ogunniyi, MD

  University of Ibadan, Nigeria

  PRINCIPAL INVESTIGATOR

• Akin Adebiyi

  University of Ibadan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Willliam Gray

Study Record Dates

• First Submitted: August 30, 2014
• First Posted: September 8, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 21, 2021
• Results First Posted: June 21, 2021

Record last verified: 2021-05

Locations

NG (1)