Skip to content

IDEA Study Cognitive Stimulation Therapy (CST) Trial in Nigeria

Identification and Intervention for Dementia in Elderly Africans (IDEA) Study: CST Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02233530
Acronym
IDEA
Enrollment
8
Registered
2014-09-08
Start date
2014-09-30
Completion date
2015-09-30
Last updated
2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

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.

Sponsors

Grand Challenges Canada
CollaboratorOTHER
University of Ibadan
CollaboratorOTHER
Kilimanjaro Christian Medical Centre, Tanzania
CollaboratorOTHER
Newcastle University
CollaboratorOTHER
Northumbria Healthcare NHS Foundation Trust
CollaboratorOTHER
William Keith Gray
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)BaselineQuality 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.

Secondary

MeasureTime frameDescription
IDEA Cognitive ScreenBaselineCognitive assessment in patients
Hospital Anxiety and Depression Scale (HADS)BaselineAnxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.
WHOQOL BrefAn average of twelve weeks from baselineQuality 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.
Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)BaselineCognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.
Study Specific Economic EvaluationBaselineAssessment of health service utilisation and time and travel for patients and carers
Zarit Burden Interview (ZBI)BaselineCarer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.

Countries

Nigeria

Participant flow

Participants by arm

ArmCount
Intervention
Cognitive stimulation therapy participants. Participant received two sessions per week for seven weeks, with 14 sessions in total. Each session lasted between 45 and 60 minutes.
9
Total9

Baseline characteristics

CharacteristicIntervention
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
9 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous81 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
9 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
Nigeria
9 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 9
other
Total, other adverse events
0 / 9
serious
Total, serious adverse events
0 / 9

Outcome results

Primary

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.

Time frame: Baseline

Population: All baseline participants

ArmMeasureValue (MEDIAN)
InterventionWorld Health Organization Brief Quality of Life Measure (WHOQOL-Bref)10.3 units on a scale
Primary

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.

Time frame: An average of eight weeks from baseline

Population: All baseline participants

ArmMeasureValue (MEDIAN)
InterventionWorld Health Organization Brief Quality of Life Measure (WHOQOL-Bref)14.9 units on a scale
Secondary

Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)

Cognitive assessment in patients

Time frame: An average of twelve weeks from baseline

Secondary

Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)

Cognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.

Time frame: An average of eight weeks from baseline

ArmMeasureValue (MEDIAN)
InterventionAdapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)7 units on a scale
Secondary

Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)

Cognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.

Time frame: Baseline

ArmMeasureValue (LEAST_SQUARES_MEAN)
InterventionAdapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)12 units on a scale
Secondary

Hospital Anxiety and Depression Scale (HADS)

Anxiety and depression assessment in patients and carers

Time frame: An average of twelve weeks from baseline

Secondary

Hospital Anxiety and Depression Scale (HADS)

Anxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.

Time frame: Baseline

ArmMeasureValue (MEDIAN)
InterventionHospital Anxiety and Depression Scale (HADS)21 units on a scale
Secondary

Hospital Anxiety and Depression Scale (HADS)

Anxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.

Time frame: An average of eight weeks from baseline

ArmMeasureValue (MEDIAN)
InterventionHospital Anxiety and Depression Scale (HADS)20 units on a scale
Secondary

IDEA Cognitive Screen

Cognitive assessment in patients

Time frame: An average of twelve weeks from baseline

Secondary

IDEA Cognitive Screen

Cognitive assessment in patients

Time frame: An average of eight weeks from baseline

Secondary

IDEA Cognitive Screen

Cognitive assessment in patients

Time frame: Baseline

Secondary

Study Specific Economic Evaluation

Assessment of health service utilisation and time and travel for patients and carers

Time frame: Baseline

Secondary

Study Specific Economic Evaluation

Assessment of health service utilisation and time and travel for patients and carers

Time frame: An average of twelve weeks from baseline

Secondary

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.

Time frame: An average of twelve weeks from baseline

Secondary

Zarit Burden Interview (ZBI)

Carer burden assessment

Time frame: An average of twelve weeks from baseline

Secondary

Zarit Burden Interview (ZBI)

Carer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.

Time frame: Baseline

ArmMeasureValue (MEDIAN)
InterventionZarit Burden Interview (ZBI)18 units on a scale
Secondary

Zarit Burden Interview (ZBI)

Carer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.

Time frame: An average of eight weeks from baseline

ArmMeasureValue (MEDIAN)
InterventionZarit Burden Interview (ZBI)11 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026