Trial record 5 of 2487 for:    Dementia

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

This study has been completed.
Sponsor:
Collaborators:
The Dementia Society of Goa, India
Goa Medical College
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00479271
First received: May 25, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 July 28, 2014