DementiaIDEANCT02229474
IDEA Study Cognitive Stimulation Therapy (CST) Trial in Tanzania
A study testing CST Intervention in people with Dementia, run by William Keith Gray at 1 site in Tanzania.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- CST Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTanzania
- Study dates
- Sep 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Anyone with dementia living within the study site
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Intervention for Dementia in Elderly Africans (IDEA) Study: CST Trial
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
Read the 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
- Conditions
- Dementia
- Being tested
- CST Intervention
- 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
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CST InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CST intervention | Experimental | 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. Receives: Behavioral: CST Intervention |
| Group 2 | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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
Measured: Immediately post-intervention
Secondary outcomes (9)
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.
Measured: Four weeks post intervention
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Immediately post-intervention
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.
Measured: Immediately post-intervention
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.
Measured: Immediately post-intervention
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.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Keith Gray
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, University of Ibadan, Kilimanjaro Christian Medical Centre, Tanzania, Newcastle University, Northumbria Healthcare NHS Foundation Trust
- Responsible party
- Sponsor-investigator, William Keith Gray, Northumbria Healthcare NHS Foundation Trust
- Investigators
- Adesola Ogunniyi, MD, Principal investigator, University of Ibadan, Ibadan, NigeriaRichard W Walker, MD, Study chair, Northumbra Healthcare NHS Foundation TrustDelare Mushi, Study director, Kilimanjaro Christian Medical University CollegeCatherine L Dotchin, MD, Study director, Northumbria Healthcare NHS Foundation TrustWilliam K Gray, PhD, Study director, Northumbria Healthcare NHS Foundaion Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229474
- Sponsor's protocol ID
- IDEA_TANZANIA_CST1
- Acronym
- IDEA
- Status last verified
- Sep 2017
- First submitted
- 28 Aug 2014
- Last updated
- 9 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will publish our findings in academic journals and state that we will make anonymized participant level data available in the manuscript, upon request to the authors.
Publications
Longdon AR, Paddick SM, Kisoli A, Dotchin C, Gray WK, Dewhurst F, Chaote P, Teodorczuk A, Dewhurst M, Jusabani AM, Walker R. The prevalence of dementia in rural Tanzania: a cross-sectional community-based study. Int J Geriatr Psychiatry. 2013 Jul;28(7):728-37. doi: 10.1002/gps.3880. Epub 2012 Sep 20.
PubMed 22996739Gray 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.
PubMed 24578459Lok N, Buldukoglu K, Barcin E. Effects of the cognitive stimulation therapy based on Roy's adaptation model on Alzheimer's patients' cognitive functions, coping-adaptation skills, and quality of life: A randomized controlled trial. Perspect Psychiatr Care. 2020 Jul;56(3):581-592. doi: 10.1111/ppc.12472. Epub 2020 Jan 12.
PubMed 31930518
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Intervention for Dementia in Elderly Africans (IDEA) Study: CST Trial
- ClinicalTrials.gov ID
- NCT02229474
- Acronym / sponsor ID
- IDEA / IDEA_TANZANIA_CST1
- Conditions
- Dementia
- Keywords
- Dementia, Cognitive Stimulation Therapy, Quality of life, Cognitive impairment, Africa, Tanzania, Nigeria, Low- and Middle-income countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- William Keith GrayUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, University of Ibadan, Kilimanjaro Christian Medical Centre, Tanzania, Newcastle University, Northumbria Healthcare NHS Foundation Trust
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Posted 9 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CST intervention | Experimental | Behavioral: CST InterventionWe 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. |
| Group 2 | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Anyone with dementia living within the study site
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CST InterventionThe 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. | Behavioural | CST intervention |
Primary outcome
World Health Organization Brief Quality of Life Scale
Time frame: Baseline
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
World Health Organization Brief Quality of Life Scale
Time frame: Immediately post-intervention
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
9 secondary outcomes
World Health Organization Brief Quality of Life Scale
Time frame: Four weeks post intervention
Identification and Intervention for Elderly Africans Cognitive Screen
Time frame: Baseline
Adapted Alzheimer's Disease Assessment Scale-cognitive Scale
Time frame: Baseline
Hospital Anxiety and Depression Scale
Time frame: Baseline
Zarit Burden Interview
Time frame: Baseline
Identification and Intervention for Elderly Africans Cognitive Screen
Time frame: Immediately post-intervention
Adapted Alzheimer's Disease Assessment Scale-cognitive Scale
Time frame: Immediately post-intervention
Hospital Anxiety and Depression Scale
Time frame: Immediately post-intervention
Zarit Burden Interview
Time frame: Immediately post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22996739Longdon AR, Paddick SM, Kisoli A, Dotchin C, Gray WK, Dewhurst F, Chaote P, Teodorczuk A, Dewhurst M, Jusabani AM, Walker R. The prevalence of dementia in rural Tanzania: a cross-sectional community-based study. Int J Geriatr Psychiatry. 2013 Jul;28(7):728-37. doi: 10.1002/gps.3880. Epub 2012 Sep 20.
- Background: PubMed 24578459Gray 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.
- Derived from this study: PubMed 31930518Lok N, Buldukoglu K, Barcin E. Effects of the cognitive stimulation therapy based on Roy's adaptation model on Alzheimer's patients' cognitive functions, coping-adaptation skills, and quality of life: A randomized controlled trial. Perspect Psychiatr Care. 2020 Jul;56(3):581-592. doi: 10.1111/ppc.12472. Epub 2020 Jan 12.
- Individual participant dataSharing planned: Yes. We will publish our findings in academic journals and state that we will make anonymized participant level data available in the manuscript, upon request to the authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adesola Ogunniyi, MD principal investigator
University of Ibadan, Ibadan, Nigeria
Richard W Walker, MD study chair
Northumbra Healthcare NHS Foundation Trust
Delare Mushi study director
Kilimanjaro Christian Medical University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CST Intervention in people with Dementia, run by William Keith Gray at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Brief Quality of Life Scale (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02229474, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.