Trial no.:	PACTR202211700581839	Date of Approval:	24/11/2022
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Evaluation of the Uganda Adopted version of the WHO-iSupport intervention for caregivers of persons with Alzheimer's disease and related Dementias (ADRD)

Official scientific title

Cultural Adaptation and evaluation of the WHO iSupport intervention for reduction of psychological distress among Caregivers of older persons with Alzheimer’s Disease and Related Dementias (ADRD) in Uganda.

Brief summary describing the background and objectives of the trial

Background: As Alzheimer’s disease and related dementias (ADRD) are a chronic illness, representing an ongoing decline in functioning, a substantial part of its management requires home based caregiving. Successful family caregiving for dementia patients is a major social and clinical challenge. Family caregivers face major stressful emotional, social and economic burdens, and the negative consequences associated with caregiving are well documented. Given the projected global increase in the number of people with dementia (82 million by 2030 and 152 million by 2050 plus a current in-patient prevalence of 6.3% in Uganda), there is paucity of information regarding the challenges that family caregivers of persons with ADRD go through in many settings in sub-Sahara Africa, including Uganda. This study will contribute to a culturally appropriate intervention for caregivers of persons with ADRD in Uganda. Objective: To investigate the current approaches that caregivers use in the support of persons with ADRD, so as to inform the adaptation of the WHO iSupport intervention for Uganda. Methods: This will be a mixed methods study involving a randomized controlled trial of the effectiveness of the Adapted WHO iSupoort (A- iSupport) in the alleviation of distress and improvement of QoL among family caregivers of persons with ADRD in Uganda. The study will be conducted in Nansana and Busukuma town councils, Wakiso-Uganda. Caregivers of patients with ADRD will be recruited into the study. Data will be collected by the researcher and trained research assistants. Four studies will be conducted; Study 1 will explore ways in which older people in the community of Wakiso district conceptualize ADRD and what informs their opinions 2. Will be to assess caregiver distress, non-professional techniques of patient care, quality of life and the associated factors among family caregivers of persons with ADRD in Wakiso district. Uganda; 3. This will be a cultural adaptation study involving 2 sub studies. Sub study 1 will adapt and pre-test the WHO-iSupport for family caregivers of persons with ADRD in Wakiso, Uganda; and sub study 2. will determine the effectiveness of A-iSupport in the alleviation of distress and improvement of QoL among family caregivers of persons with ADRD in Wakiso, Uganda. Outcomes: The primary outcome of this study is the adaptation of the WHO-iSupport psychotherapy. Analysis: Primary analyses will be based on Intention to treat (ITT) principle to avoid any biases that may occur by subjective choice of ineligible subjects. Summary statistics like age will be given as a mean (SD) while for categorical data will be given as a proportion and summarized in tables and graphs. To assess for the hypothesis, questionnaires will be transformed into a linear scale, and a t-test will be used to determine the difference in the two groups (Intervention and Control) given as a difference with a P-value. ANOVA will be used to assess for the differences between the time intervals.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Mental and Behavioural Disorders

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Psychosocial

Anticipated trial start date

30/01/2023

Actual trial start date

01/02/2023

Anticipated date of last follow up

31/05/2023

Actual Last follow-up date

31/08/2023

Anticipated target sample size (number of participants)

119

Actual target sample size (number of participants)

109

Recruitment status

Not yet recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using by using procedures such as coin-tossing or dice-rolling	Numbered containers	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	Adopted WHO iSupport	Once a week call to check in with the participant	6 weeks	The WHO’s iSupport is a skills and training programme for caregivers of people with ADRD. The iSupport aims to prevent and/or decrease mental and physical health problems associated with providing care and to improve the quality of life of those caring for people with dementia (WHO 2019). The iSupport manual includes five modules and accompanying exercises, namely: (i) introduction to dementia; (ii) being a caregiver; (iii) caring for me; (iv) providing everyday care; and (v) dealing with behaviour changes (WHO 2019). iSupport is a self-help tool for caregivers of people with dementia, including family members, relatives and friends and can be adapted to national or local contexts and needs (WHO 2019). Once adapted, carers can choose to work through all modules and lessons consecutively or select the lessons that are the most relevant to their everyday lives (WHO 2019). All lessons consist of brief readings, descriptive examples and several exercises. Carers receive feedback as they work through each exercise. For this study, the iSupport will be interviewer-administered because of the possible variations in education and reading abilities of the caregivers. No known studies have been published in regard to the adaptation of the iSupport, however the Bangor study that is currently underway in UK, is looking at adaptation of the iSupport for the UK population	54	Placebo
Experimental Group	Adopted WHO iSupport	1 hour training once a week	6 weeks	The WHO’s iSupport is a skills and training programme for caregivers of people with ADRD. The iSupport aims to prevent and/or decrease mental and physical health problems associated with providing care and to improve the quality of life of those caring for people with dementia (WHO 2019). The iSupport manual includes five modules and accompanying exercises, namely: (i) introduction to dementia; (ii) being a caregiver; (iii) caring for me; (iv) providing everyday care; and (v) dealing with behaviour changes (WHO 2019). iSupport is a self-help tool for caregivers of people with dementia, including family members, relatives and friends and can be adapted to national or local contexts and needs (WHO 2019). Once adapted, carers can choose to work through all modules and lessons consecutively or select the lessons that are the most relevant to their everyday lives (WHO 2019). All lessons consist of brief readings, descriptive examples and several exercises. Carers receive feedback as they work through each exercise. For this study, the iSupport will be interviewer-administered because of the possible variations in education and reading abilities of the caregivers. No known studies have been published in regard to the adaptation of the iSupport, however the Bangor study that is currently underway in UK, is looking at adaptation of the iSupport for the UK population	55

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Caregivers of persons with ADRD residing in Wakiso district for the last 12 months	Declines to consent. Respondents who are very ill and can neither sit or talk thus limiting use of the assessment tools. Individuals who will screen positive for a possible Dementia on the Mini Cog	80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s)	19 Year(s)	90 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

29/09/2022

SOMREC

Ethics Committee Address
Street address	City	Postal code	Country
7072 Mulago Hill	Kampala	256	Uganda

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Effectiveness of A-iSupport in reduction of caregiver distress as measured by the caregiver distress assessment scale at baseline at 3 months’ post intervention.	Base line, at 3 weeks, 6 weeks and 6 weeks after study
Secondary Outcome	Fidelity of the A-iSupport Applicability of A-iSupport	At base line

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Nansana town council	Sub council offices	Nansana		Uganda
Busukuma town council	Busukuma	Busukuma		Uganda

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Research Training and mentorship to strengthen brain health across the Life span in Uganda Grant Number D43NS118560	7072	Kampala	256	Uganda

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Research Training and mentorship to strengthen brain health across the Life span in Uganda Grant Number D43NS118560	7072	Mulago	256	Uganda	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Joy Louise Gumikiriza	joyonoria@gmail.com	+256782904038	7072 Mulago Hill
City	Postal code	Country	Position/Affiliation
Kampala	256	Uganda	Assistant Lecturer and PhD fellow
Role	Name	Email	Phone	Street address
Scientific Enquiries	Noeline Nakasujja	drnoelin@gmail.com	+256772419700	7072 Mulago Hill
City	Postal code	Country	Position/Affiliation
Kampala	256	Uganda	Assoc Professor and Chair Department of Psychiatry
Role	Name	Email	Phone	Street address
Public Enquiries	Janet Nakigudde	janetnakigudde@gmail.cm	+256772407885	7072 Mulago Hill
City	Postal code	Country	Position/Affiliation
Kampala	256	Uganda	Lecturer Department of Psychiatry

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	I will share the unidentified data with the team to protect the participants. I will also hare results from the study.	Informed Consent Form,Statistical Analysis Plan,Study Protocol	within 12 months of study completion	I will share access to google drives
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry