Evaluating the Effectiveness of a Community Based Intervention for Persons With Dementia and Their Caregivers in a Developing Country

This study has been completed.

First Received on May 25, 2007. No Changes Posted

Sponsor:	London School of Hygiene and Tropical Medicine
Collaborators:	The Dementia Society of Goa, India Goa Medical College
Information provided by:	London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT00479271

Purpose

The aim of this trial was to apply a home based, flexible, stepped-care intervention designed to improve the awareness and knowledge of family caregivers regarding dementia, to maximise their caregiving resources and to improve their caregiving skills. A RCT will be used to evaluate the same wherein the intervention group will get the services immediately and the control arm would receive the same after a period of 6 months.

Condition	Intervention
Dementia Behavioral Symptoms Mental Health	Behavioral: Home based, flexible, stepped care intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Supportive Care
Official Title:	The Dementia Home Care Project: a Randomised Controlled Trial to Evaluate the Effectiveness of a Home Care Program for Supporting Caregivers of Persons With Dementia in Developing Countries: a Randomised Controlled Trial From Goa, India

Resource links provided by NLM:

MedlinePlus related topics: Caregivers Dementia Mental Health

U.S. FDA Resources

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:

Primary Outcome Measure(s) evaluate the efficacy and cost-effectiveness of the intervention in reducing carer burden, improving behaviour problems in elderly persons with dementia and reducing the costs of illness. [ Time Frame: by the end of the study ]

Secondary Outcome Measures:

Measure the service requirements, average number of visits by Home Care Advisor, visits by Psychiatrists, need for medication, effect of intervention on survival and overall quality of life of the person with dementia as well as the carer [ Time Frame: by the end of the trial ]

Study Start Date:	October 2003
Study Completion Date:	February 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All probable cases will be examined by a trained clinician (AD) to confirm the diagnosis of dementia according to DSM IV criteria and graded using the Clinical Dementia Rating (CDR) Scale.
CDR mild and moderate dementia.
The principal caregiver, as identified by the family, was enrolled for the trial. The principal caregiver was generally the spouse, although in some instances another family member was the principal caregiver, particularly when the spouse was not in a position to care.

Exclusion Criteria:

CDR severe dementia or severe co-morbid physical health conditions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479271

Locations

India
The Dementia Society of Goa
Porvorim, Goa, India, 403521

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

The Dementia Society of Goa, India

Goa Medical College

Investigators

Principal Investigator:	Vikram Patel	London School of Hygiene and Tropical Medicine
Principal Investigator:	Amit Dias, MD,DGM,DTM&H	The Dementia Society of Goa, & Goa Medical College

More Information

No publications provided by London School of Hygiene and Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dias A, Dewey ME, D'Souza J, Dhume R, Motghare DD, Shaji KS, Menon R, Prince M, Patel V. The effectiveness of a home care program for supporting caregivers of persons with dementia in developing countries: a randomised controlled trial from Goa, India. PLoS ONE. 2008 Jun 4;3(6):e2333.

ClinicalTrials.gov Identifier:	NCT00479271 History of Changes
Other Study ID Numbers:	DSG001
Study First Received:	May 25, 2007
Last Updated:	May 25, 2007
Health Authority:	India: Ministry of Social Justice and empowerment, Govt. of India

Keywords provided by London School of Hygiene and Tropical Medicine:

RCT
Dementia
community trial
Homebased care
caregiver burden

Behavioural problems
Dementia in subjects
behavioral problems in subjects
Mental health of carers

Additional relevant MeSH terms:

Behavioral Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012