NCT00479271

Brief Summary

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 Randomized Controlled Trial (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
Last Updated

April 1, 2015

Status Verified

May 1, 2007

Enrollment Period

1.3 years

First QC Date

May 25, 2007

Last Update Submit

March 31, 2015

Conditions

DementiaBehavioral SymptomsMental Health

Keywords

RCTDementiacommunity trialHomebased carecaregiver burdenBehavioural problemsDementia in subjectsbehavioral problems in subjectsMental health of carers

Outcome Measures

Primary Outcomes (1)

  • 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.

    by the end of the study

Secondary Outcomes (1)

  • 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

    by the end of the trial

Study Arms (2)

Home Care

ACTIVE COMPARATOR

A flexible home-care program tailored to the needs of the individual and the family. The components of the intervention will include: 1. Basic education about dementia (what is the disease, its course, its features etc) 2. Education about common behaviour problems and how they can be managed 3. Support to the carer, for example for an elderly carer living alone with the patient, in activities of daily living 4. Referral to specialists when behaviour problems are severe and warrant medication intervention (sedatives).

Behavioral: Home based, flexible, stepped care intervention

Wait-list

OTHER

This group will be put on a waiting list to receive the intervention after 6 months. Families will be free to choose any health care they desire during the waiting period.

Behavioral: Home based, flexible, stepped care intervention after 6 months. Families will be free to choose any health care they desire during the waiting period.

Interventions

Home based, flexible, stepped care interventionBEHAVIORAL

Home based, flexible, stepped care intervention

Home Care
Home based, flexible, stepped care intervention after 6 months. Families will be free to choose any health care they desire during the waiting period.BEHAVIORAL

Home based, flexible, stepped care intervention after 6 months. Families will be free to choose any health care they desire during the waiting period.

Wait-list

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Dementia Society of Goa

Porvorim, Goa, 403521, India

Location

Related Publications (1)

  • 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. doi: 10.1371/journal.pone.0002333.

    PMID: 18523642DERIVED

MeSH Terms

Conditions

DementiaBehavioral SymptomsPsychological Well-BeingCaregiver BurdenMental Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersBehaviorPersonal SatisfactionStress, Psychological

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2007

First Posted

May 28, 2007

Study Start

October 1, 2003

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

April 1, 2015

Record last verified: 2007-05

Locations

IN(1)