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IDEA Study Cognitive Stimulation Therapy (CST) Trial in Tanzania

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02229474
Acronym
IDEA
Enrollment
34
Registered
2014-09-01
Start date
2014-09-30
Completion date
2015-09-30
Last updated
2018-04-09

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. We aim seek to improve quality of life for people with dementia and their caregivers. Within this trial of CST, we hypothesise that CST can significantly improve the quality of people with dementia and their carers living in Africa

Detailed description

Our 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. We 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 we 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 we will initiate training of local healthcare workers in diagnosis and management of people with dementia. In Phase II we will engage with local communities to raise awareness of dementia. Building on previous work at both study sites, we 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. We 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. We 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 we 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 we 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 we hope that the training will ultimately be led by caregivers allowing such therapy to become sustainable within communities in the longer term. We will evaluate changes in cognition in people with dementia, and quality of life (QOL) in both people with dementia and their caregivers, post-intervention. We 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 Tanzania

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
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

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 ScaleBaselineThe WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale

Secondary

MeasureTime frameDescription
World Health Organization Brief Quality of Life ScaleFour weeks post interventionThe scale will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale.
Identification and Intervention for Elderly Africans Cognitive ScreenBaselineThe screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.
Adapted Alzheimer's Disease Assessment Scale-cognitive ScaleBaselineThe adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.
Hospital Anxiety and Depression ScaleBaselineThe scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.
Zarit Burden InterviewBaselineThe scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.

Countries

Tanzania

Participant flow

Participants by arm

ArmCount
CST Intervention
We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis. 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. We 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. CST Intervention: 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 outcomes
16
Group 2
and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
18
Total34

Baseline characteristics

CharacteristicCST InterventionGroup 2Total
Age, Continuous81 years80 years80 years
Sex: Female, Male
Female
14 Participants15 Participants29 Participants
Sex: Female, Male
Male
2 Participants3 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 160 / 18
serious
Total, serious adverse events
0 / 160 / 18

Outcome results

Primary

World Health Organization Brief Quality of Life Scale

The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale

Time frame: Baseline

Population: Analysis for QOL data comparing pre- and post intervention scores

ArmMeasureValue (MEDIAN)
CST InterventionWorld Health Organization Brief Quality of Life Scale2.5 units on a scale
Group 2World Health Organization Brief Quality of Life Scale2 units on a scale
Primary

World Health Organization Brief Quality of Life Scale

The WHOQOL-Bref will assess quality of life in patients and carers. The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale

Time frame: Immediately post-intervention

Population: Groups attending CST sessions

ArmMeasureValue (MEDIAN)
CST InterventionWorld Health Organization Brief Quality of Life Scale2.5 units on a scale
Group 2World Health Organization Brief Quality of Life Scale2.5 units on a scale
Secondary

Adapted Alzheimer's Disease Assessment Scale-cognitive Scale

The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.

Time frame: Baseline

Population: people attending CST

ArmMeasureValue (MEAN)Dispersion
CST InterventionAdapted Alzheimer's Disease Assessment Scale-cognitive Scale31.5 units on a scaleStandard Deviation 8.358
Group 2Adapted Alzheimer's Disease Assessment Scale-cognitive Scale27.4 units on a scaleStandard Deviation 6.647
Secondary

Adapted Alzheimer's Disease Assessment Scale-cognitive Scale

The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.

Time frame: Immediately post-intervention

Population: People attending CST

ArmMeasureValue (MEAN)Dispersion
CST InterventionAdapted Alzheimer's Disease Assessment Scale-cognitive Scale23.4 units on a scaleStandard Deviation 8.56
Group 2Adapted Alzheimer's Disease Assessment Scale-cognitive Scale26.6 units on a scaleStandard Deviation 7.121
Secondary

Hospital Anxiety and Depression Scale

The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.

Time frame: Baseline

Population: People attending CST

ArmMeasureValue (MEDIAN)
CST InterventionHospital Anxiety and Depression Scale8 units on a scale
Group 2Hospital Anxiety and Depression Scale5.5 units on a scale
Secondary

Hospital Anxiety and Depression Scale

The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.

Time frame: Immediately post-intervention

Population: People attending CST

ArmMeasureValue (MEDIAN)
CST InterventionHospital Anxiety and Depression Scale9.0 units on a scale
Group 2Hospital Anxiety and Depression Scale7.5 units on a scale
Secondary

Identification and Intervention for Elderly Africans Cognitive Screen

The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.

Time frame: Immediately post-intervention

Population: People attending CST

ArmMeasureValue (MEDIAN)
CST InterventionIdentification and Intervention for Elderly Africans Cognitive Screen5 units on a scale
Group 2Identification and Intervention for Elderly Africans Cognitive Screen6.5 units on a scale
Secondary

Identification and Intervention for Elderly Africans Cognitive Screen

The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.

Time frame: Baseline

Population: people attending CST

ArmMeasureValue (MEDIAN)
CST InterventionIdentification and Intervention for Elderly Africans Cognitive Screen6 units on a scale
Group 2Identification and Intervention for Elderly Africans Cognitive Screen5 units on a scale
Secondary

World Health Organization Brief Quality of Life Scale

The scale will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale.

Time frame: Four weeks post intervention

Population: people atending CST sessions

ArmMeasureValue (MEDIAN)
CST InterventionWorld Health Organization Brief Quality of Life Scale2.5 units on a scale
Group 2World Health Organization Brief Quality of Life Scale2.5 units on a scale
Secondary

Zarit Burden Interview

The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.

Time frame: Baseline

Population: People attending CST

ArmMeasureValue (MEDIAN)
CST InterventionZarit Burden Interview12.5 units on a scale
Group 2Zarit Burden Interview17.5 units on a scale
Secondary

Zarit Burden Interview

The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.

Time frame: Immediately post-intervention

Population: people attending CST

ArmMeasureValue (MEDIAN)
CST InterventionZarit Burden Interview9.5 units on a scale
Group 2Zarit Burden Interview13.0 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026