CTRI Number |
CTRI/2017/02/007876 [Registered on: 15/02/2017] Trial Registered Prospectively |
Last Modified On: |
01/09/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [internet based caregiver support programme] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A study to test the effectiveness of an internet-based program to support caregivers of persons with dementia |
Scientific Title of Study
Modification(s)
|
iSupport for Dementia Family Caregivers |
Secondary IDs if Any
|
Secondary ID |
Registry |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Dr Mathew Varghese |
Address |
Department of Psychiatry, NIMHANS
Hosur Road
Bangalore
Bangalore KARNATAKA 560029 India |
Phone |
080-2699-5269 |
Fax |
|
Email |
mat.varg@yahoo.com |
|
Details Contact Person Scientific Query
Modification(s)
|
Name |
Dr Mathew Varghese |
Address |
Department of Psychiatry, NIMHANS
Hosur Road
Bangalore
Bangalore KARNATAKA 560029 India |
Phone |
080-2699-5269 |
Fax |
|
Email |
mat.varg@yahoo.com |
|
Details Contact Person Public Query
Modification(s)
|
Name |
Dr Mathew Varghese |
Address |
Department of Psychiatry, NIMHANS
Hosur Road
Bangalore
Bangalore KARNATAKA 560029 India |
Phone |
080-2699-5269 |
Fax |
|
Email |
mat.varg@yahoo.com |
|
Source of Monetary or Material Support
Modification(s)
|
Grant awarded from Alzheimers Association National Office, 225 N. Michigan Ave., Fl. 17, Chicago, IL 60601 to World Health Organization (WHO),
20 Avenue Appia,
1211 Geneva 27
Switzerland |
|
Primary Sponsor
Modification(s)
|
Name |
Dr Mathew Varghese |
Address |
Professor of Psychiatry,
Department of Psychiatry, NIMHANS
Hosur Road, Bangalore 560029
|
Type of Sponsor |
Other [Principal Investigator & Professor of Psychiatry, NIMHANS, Hosur Road, Bangalore-560029] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Mathew Varghese |
NIMHANS |
Griatric Clinic and Services, Department of Psychiatry, NIMHANS
Hosur Road
Bangalore 560029
Bangalore |
9480829468
mat.varg@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 4 |
Name of Committee |
Approval Status |
NIMHANS Ethics Committee |
Approved |
NIMHANS Ethics Committee |
Approved |
NIMHANS Ethics Committee |
Approved |
NIMHANS Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Dementia |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
control |
This companion website will contain currently available information about relevant topics on dementia symptoms and how to recognize caregivers stress. There will be no restriction on what other sites the caregivers in the education only group can access. The education only website will be information-focused (not skills training focused). Information will be presented with no interactive features. Thus the education only website will be similar to existing dementia-focused websites and to the static information provided by the iSupport portal. It will present information in a lecture-style format and does not take advantage of other features that the interactive website can provide. |
Intervention |
iSupport |
“iSupport” is the name of the overall online portal. This includes static information (for information purposes only) which is open access to all users. Specific content can be reached only after a log in page, including data logging tools, the tailored self-help modules and “communication tools”. The content will be theoretically based on principles of cognitive behavioral therapy (CBT) and will be informed by a detailed review of existing evidence-based programs to reduce caregiver burden that is conducted by WHO. It will be problem-oriented and personalized. It will consist of a number of modules that are recommended to follow for each caregiver. Further, caregivers will be guided to additional modules dependent on their needs as identified in the initial assessment online completed at log in. Teaching of self-care skills will be done in a gentle comforting and supportive environment so that the caregivers feel that the portal will make their life easier. The content of these modules will cover a number of areas, including: (1) an introduction to dementia (2) how to perform everyday care for a person with dementia (3) stress management and coping and (4) how to manage difficult behaviors. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Both |
Details |
1) Be aged 18 years or older
2) Self report that they are a family caregiver of a person with dementia
3) The care recipient has Alzheimer disease or related dementia as determined by caregivers self-reported medical diagnosis
4) A score of 4 or higher on a one item burden scale ranging from 1 to 10 or a score greater than 3 on the Hospital Anxiety and Depression Scale Anxiety subscale (HADS A) or a score greater than 2 on the Centre for Epidemiological Studies Depression scale (CES D)
5) Access to reliable internet and computer and report that they are regular users for health information on the internet
|
|
ExclusionCriteria |
Details |
People will be excluded from taking part in the study when they:
1) Are not able to comprehend written English
2) Score 15 or higher on the 10-item CESD for depression which indicates a clinical depression
3) Are judged by a clinician to experience intolerable stress |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Subjective Burden (Mean Zarit burden scale score)
Depression (Mean score on Center for Epidemiological Studies Depression-10 item scale)
Anxiety (Mean score on the anxiety subscale of the Hospital Anxiety and Depression Scale) |
3 months, 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Quality of life (Mean EuroQol 5D scale score)
Self-Efficacy (Mean score on RIS Eldercare Self-Efficacy Scale) |
3 months, 6 months |
|
Target Sample Size
|
Total Sample Size="430" Sample Size from India="430" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
22/02/2017 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Brief Summary
Modification(s)
|
This study is a randomized, parallel group, active controlled trial comparing effects of the iSupport portal compared to an education only control condition (EOC) in family caregivers of people with dementia who experience burden or mild to moderate symptoms of depression. The primary outcome measures will be subjective burden (Mean Zarit burden scale score), Depression (Mean score on Center for Epidemiological Studies Depression-10 item scale) and Anxiety (Mean score on the anxiety subscale of the Hospital Anxiety and Depression Scale) at 3 months and 6 months. The secondary outcomes will be Quality of life (Mean EuroQol 5D scale score) and Self-Efficacy (Mean score on RIS Eldercare Self-Efficacy Scale) at 3 months and 6 months. |