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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Detailed Description
Service development for older people with dementia in India needs to take account of the fact that dementia tends to be a hidden problem. Thus, dementia is generally perceived to be part of normal ageing, and not a health condition, and families rarely present to health services, who are generally ignorant of most cases in their community. Health services are often ill-equipped to meet the needs of older persons. Health care, even primary care, is clinic-based; the older person must attend the clinic or hospital, often involving a long journey and waiting time. The assessment and treatment that they receive is orientated towards acute rather than chronic conditions. Thus, home-based interventions provide a practical alternative to clinic-based interventions for persons affected by dementia.
The probable cases of dementia will be identified with the help of key informants (doctors, priests, health workers, local leaders) in two of the most populated talukas of Goa (Bardez and Tiswadi,). All probable cases will be examined by a trained clinician to confirm the diagnosis of dementia. Cases will be randomized to receive the intervention or placed in a waiting list group who will receive the intervention after 6 months. The intervention will be delivered by a trained community Home Care Advisors (HCA), supported when required by the Principal Investigators and clinical consultants. The principal outcomes being evaluated are carer burden and mental health, behavioral problems in the person with dementia, and costs of illness.
Objectives
The project has two specific objectives:
- To adapt and apply a 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.
- To 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Home Care
A flexible home-care program tailored to the needs of the individual and the family. The components of the intervention will include:
- Basic education about dementia (what is the disease, its course, its features etc)
- Education about common behaviour problems and how they can be managed
- Support to the carer, for example for an elderly carer living alone with the patient, in activities of daily living
- Referral to specialists when behaviour problems are severe and warrant medication intervention (sedatives).
Intervention: Home based, flexible, stepped care intervention (Behavioral)
Wait-list
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.
Intervention: 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)
Outcomes
Primary Outcomes
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 Outcomes
- 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)