FULL DETAILS (Read-only)

CTRI Number  CTRI/2017/02/007876 [Registered on: 15/02/2017] Trial Registered Prospectively
Last Modified On: 03/10/2019
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  
Name  Address 
NIL  NIL 
 
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= 3  
Name of Committee  Approval Status 
NIMHANS Ethics Committee  Approved 
NIMHANS Ethics Committee  Approved 
NIMHANS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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   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  

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