IDEA Study Cognitive Stimulation Therapy (CST) Trial in Tanzania

NCT02229474 | Completed Results DMC

• 1 other identifier: IDEA_TANZANIA_CST1
• Study Type: interventional
• Target: 34
• 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. 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

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 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

  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

  Immediately post-intervention

Secondary Outcomes (9)

• World Health Organization Brief Quality of Life Scale

  Four weeks post intervention

• Identification and Intervention for Elderly Africans Cognitive Screen

  Baseline

• Adapted Alzheimer's Disease Assessment Scale-cognitive Scale

  Baseline

• Hospital Anxiety and Depression Scale

  Baseline

• Zarit Burden Interview

  Baseline

Study Arms (2)

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.

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.

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)

Hai district DSS

Moshi, Kilimanjaro, Tanzania

Location

Related Publications (3)

• 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.

  PMID: 22996739 BACKGROUND

• 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

• Lok 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.

  PMID: 31930518 DERIVED

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: Professor Richard Walker
• Organization: Northumbria Healthcare NHS Foundation Trust

richard.walker@nhct.nhs.uk

+441912932709

Study Officials

• Adesola Ogunniyi, MD

  University of Ibadan, Ibadan, Nigeria

  PRINCIPAL INVESTIGATOR

• Richard W Walker, MD

  Northumbra Healthcare NHS Foundation Trust

  STUDY CHAIR

• Delare Mushi

  Kilimanjaro Christian Medical University College

  STUDY DIRECTOR

• Catherine L Dotchin, MD

  Northumbria Healthcare NHS Foundation Trust

  STUDY DIRECTOR

• William K Gray, PhD

  Northumbria Healthcare NHS Foundaion Trust

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr William Gray

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 1, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 9, 2018
• Results First Posted: April 9, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

TA (1)