Clinical trial NCT02233530: IDEA Study Cognitive Stimulation Therapy (CST) Trial in Nigeria
Official title: Identification and Intervention for Dementia in Elderly Africans (IDEA) Study: CST Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Northumbria Healthcare NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: University of Ibadan
name: Kilimanjaro Christian Medical Centre, Tanzania
name: Newcastle University
name: Northumbria Healthcare NHS Foundation Trust
First posted: 2014-09-08
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: The project will address three specific challenges: 1) Integrate screening and core packages of services into routine primary health care. 2) Provide effective and affordable community-based care and rehabilitation. 3) Develop effective treatment for use by non-specialists, including lay healthcare workers with minimal training.

Dementia is under-diagnosed in sub-Saharan Africa (SSA) and treatment is rarely accessed or available. The burden of dementia on caregivers is high, with loss of income, and psychosocial stress common. However, large scale screening for dementia in such a setting is neither affordable nor sustainable. The purpose of this 3 year project is to provide a sustainable mechanism for diagnosis and therapeutic intervention for people with dementia. The investigators will use 2 complimentary, rural study sites, 1 in Nigeria, West Africa and 2 in Tanzania, East Africa. As a consequence our results should be generalizable to all SSA. Our approach is inexpensive and will have applicability to other low- and middle-income countries.

During Phase I the investigators will validate a screening tool, previously developed by members of our study team from data collected in Tanzania, and carry out a pilot study of the benefits of cognitive stimulation therapy (CST) when used in SSA for those already identified with dementia. During both of these activities the investigators will initiate training of local healthcare workers in diagnosis and management of people with dementia. In Phase II the investigators will engage with local communities to raise awareness of dementia. Building on previous work at both study sites, the investigators will initiate poster, newspaper and radio advertising and use mobile phone text messaging services (for relevant healthcare personnel) to increase awareness of the need to diagnose and intervene at an early stage. The investigators will empower local private pharmacies to help identify people with dementia, a relationship which will ultimately be mutually beneficial through the supply of medicines to treat risk factors for dementia, such as hypertension. The investigators will engage with local community leaders and government officials to assist us in this awareness raising, an approach that has proven successful in previous studies by our team in SSA. One of our study team (Dr Mushi (DM)) is a social scientist based in Tanzania and during Phase II the investigators will conduct qualitative research into attitudes and beliefs surrounding dementia and identify any barriers to diagnosis in both sites. The results of this research will be fed back to inform other phases of the study. Finally, in phase III the investigators will initiate a program of community based CST led by local occupational therapists (OTs) and nurse specialists. OTs and nurses will train caregivers in CST techniques and the investigators hope that the training will ultimately be led by caregivers allowing such therapy to become sustainable within communities in the longer term. The investigators will evaluate changes in cognition in people with dementia, and quality of life (QOL) in both people with dementia and their caregivers, post-intervention. The investigators will carry out a full economic evaluation of the effect of our program, to be led by a heath economist based at Newcastle University, United Kingdom.

This protocol cover the CST trial (Phase III of the study) in Nigeria

Eligibility 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

Primary outcomes:
measure: World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)
timeFrame: Baseline
measure: World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)
timeFrame: An average of eight weeks from baseline
Secondary outcomes:
measure: WHOQOL Bref
timeFrame: An average of twelve weeks from baseline
measure: IDEA Cognitive Screen
timeFrame: Baseline
measure: IDEA Cognitive Screen
timeFrame: An average of eight weeks from baseline
measure: IDEA Cognitive Screen
timeFrame: An average of twelve weeks from baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: An average of eight weeks from baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: An average of twelve weeks from baseline
measure: Zarit Burden Interview (ZBI)
timeFrame: Baseline
measure: Zarit Burden Interview (ZBI)
timeFrame: An average of eight weeks from baseline
measure: Zarit Burden Interview (ZBI)
timeFrame: An average of twelve weeks from baseline
measure: Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)
timeFrame: Baseline
measure: Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)
timeFrame: An average of eight weeks from baseline
measure: Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)
timeFrame: An average of twelve weeks from baseline
measure: Study Specific Economic Evaluation
timeFrame: Baseline
measure: Study Specific Economic Evaluation
timeFrame: An average of twelve weeks from baseline
Other outcomes:
Locations:
city: Lalupon
country: Nigeria
facility: Lalupon
state: Oyo State
Study officials:
affiliation: University of Ibadan, Nigeria
name: Adesola Ogunniyi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ibadan
name: Akin Adebiyi
role: STUDY_DIRECTOR
References:
citation: 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.