| CTRI Number |
CTRI/2017/06/008916 [Registered on: 27/06/2017] Trial Registered Prospectively |
| Last Modified On: |
15/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A mixed-method study exploring the use of assistive technology to support daily time management in older adults with dementia |
|
Scientific Title of Study
|
Managing Time in Dementia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sebestina Anita Dsouza |
| Designation |
Professor |
| Affiliation |
Manipal University |
| Address |
Department of Occupational Therapy, School of Allied Health Sciences, Manipal University
Udupi
KARNATAKA
576104
India |
| Phone |
2922188 |
| Fax |
|
| Email |
sebestina.dsouza@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sebestina Anita Dsouza |
| Designation |
Professor |
| Affiliation |
Manipal University |
| Address |
Department of Occupational Therapy, School of Allied Health Sciences, Manipal University
Udupi
KARNATAKA
576104
India |
| Phone |
2922188 |
| Fax |
|
| Email |
sebestina.dsouza@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sebestina Anita Dsouza |
| Designation |
Professor |
| Affiliation |
Manipal University |
| Address |
Department of Occupational Therapy, School of Allied Health Sciences, Manipal University
Udupi
KARNATAKA
576104
India |
| Phone |
2922188 |
| Fax |
|
| Email |
sebestina.dsouza@manipal.edu |
|
|
Source of Monetary or Material Support
|
| ICMR, V.Ramalingawami Bhawan, Ansari Nagar, P.O. Box: 4911, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V.Ramalingawami Bhawan, Ansari Nagar, P.O. Box: 4911, New Delhi - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Gunnel Janeslatt |
Uppsala University, Sweden |
|
|
Countries of Recruitment
|
India
Sweden |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sebestina Anita Dsouza |
Kasturba Hospital |
Dept. of Occupational Therapy, N1, First floor, Kasturba Hospital, Manipal, 576104
Udupi
KARNATAKA |
2922188
sebestina.dsouza@manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
occupational therapists, older adults, caregivers of dementia patients |
| Patients |
(1) ICD-10 Condition: G300||Alzheimers disease with early onset, (2) ICD-10 Condition: G301||Alzheimers disease with late onset, (3) ICD-10 Condition: G308||Other Alzheimers disease, (4) ICD-10 Condition: G309||Alzheimers disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Time assistive products |
These are devices used for individuals with dementia with cognitive deficits of temporal disorientation and impaired time management |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Older adults aged 65 years and above, diagnosed with mild dementia with self-rated difficulties in daily time management and willing to try the assistive product |
|
| ExclusionCriteria |
| Details |
Individuals with mental health problems or psychiatric disorders not connected to dementia, high levels of physical frailty and unable to communicate verbally |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time-S and Katid for older adult with dementia and Time Proxy for caregiver |
Baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COPM and QUEST for older adults with dementia, COPE Index for caregiver, WHO-5 for both |
Baseline, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "212"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2017 |
| Date of Study Completion (India) |
19/05/2022 |
| Date of First Enrollment (Global) |
01/09/2017 |
| Date of Study Completion (Global) |
30/11/2022 |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
in process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
India is witnessing a burgeoning ageing population due to which the needs of the elderly have been prioritized in the Indian National Health Programmes. Due to the changing family structure and dramatic socio-economic changes, family members are having difficulty in looking after their elderly suffering from any chronic illness like dementia. Ability to manage and use time influences participation and well-being. Research on Assistive Technology (AT) in developed countries suggests that it improves well-being and participation in older adults with cognitive deficits and reduces caregiver burden. There is limited evidence in India on the use of AT for time management in elderly with cognitive deficits. Also these devices are not yet available in the Indian market. Considering the experience of the Swedish collaborators in clinical use and research in using AT, this project will help explore the feasibility and acceptance of AT in a contextually different culture like India. Through collaboration with the Swedish research team, the competencies of occupational therapists in India could be enhanced in prescribing and using assistive technology. This project could aid in increasing the accessibility of these products for potential users in India. The objectives of the study are 1. To understand the perspectives of healthy Indian older adults, Indian older adults with dementia, their informal caregivers and occupational therapists on daily time management and the use of time assistive products. 2. To investigate the use of time assistive products currently used in Sweden, among Indian older adults with dementia and its impact on their daily time management and well-being 3.To explore the feasibility of time assistive products in Indian context and if needed, identify strategies to enhance the contextual relevance and acceptability of these products for Indian older adults with dementia and their informal caregivers The present study findings will help: Understand the scope of using AT in India elderly for cognitive deficits like dementia Understand the effect of AT on improving well-being and participation in older adults with dementia and reducing caregiver burden Facilitate development of indigenous, feasible and contextually relevant AT to support daily time management and develop valid assessment instruments for Indian elderly
|