CTRI Number |
CTRI/2014/01/004290 [Registered on: 06/01/2014] Trial Registered Retrospectively |
Last Modified On: |
03/01/2014 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [OCCUPATIONAL THERAPY] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Program for Elderly patients with memory disorder |
Scientific Title of Study
|
Development of new occupational therapy interventions for patients with dementia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prof A B DEY |
Designation |
PROFESSOR AND HEAD, DEPARTMENT OF GERIATRIC MEDICINE |
Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Address |
ROOM NO-3091, DEPARTMENT OF GERIATRIC MEDICINE
ACADEMIC BLOCK, 3RD FLOOR
AIIMS
South DELHI 110029 India |
Phone |
011-26593639 |
Fax |
|
Email |
abdey@hotmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof A B DEY |
Designation |
PROFESSOR AND HEAD, DEPARTMENT OF GERIATRIC MEDICINE |
Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Address |
ROOM NO-3091, DEPARTMENT OF GERIATRIC MEDICINE
ACADEMIC BLOCK, 3RD FLOOR
AIIMS
South DELHI 110029 India |
Phone |
011-26593639 |
Fax |
|
Email |
abdey@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Prof A B DEY |
Designation |
PROFESSOR AND HEAD, DEPARTMENT OF GERIATRIC MEDICINE |
Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Address |
ROOM NO-3091, DEPARTMENT OF GERIATRIC MEDICINE
ACADEMIC BLOCK, 3RD FLOOR
AIIMS
South DELHI 110029 India |
Phone |
011-26593639 |
Fax |
|
Email |
abdey@hotmail.com |
|
Source of Monetary or Material Support
|
INDIAN COUNCIL OF MEDICAL RESEARCH |
|
Primary Sponsor
|
Name |
Division of Non Communicable Disease NDIAN COUNCIL OF MEDICAL RESEARCH Ansari Nagar New Delhi |
Address |
THE DIRECTOR GENERAL
NCD-I
ICMR, ANSARI NAGAR
|
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Prof A B DEY |
MEMORY CLINIC |
DEPARTMENT OF GERIATRIC MEDICINE
ANSARI NAGAR, AIIMS South DELHI |
01126593639
abdey@hotmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTE ETHICS COMMITTEE, AIIMS |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
MILD TO MODERATE DEMENTIA, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
NOVEL OCCUPATIONAL THERAPY PROGRAM |
In addition to Medication as prescribed by Geriatrician/Psychiatrist, Novel Occupational therapy program (Relaxation for 10 minutes involved alternately tensing and releasing different group of muscles, in order to gain awareness of the difference between a tense and a relaxed state, Physical Exercises for 10 minutes aimed at maintaining strength, mobility, circulation and general health. This included Range Of Movement exercise, medicinal ball training, imitating movement of another person and squatting at different levels,Personal activities for 15 minutes which included a) personal care of body involving care of hair, skin, nails and teeth; general cleanliness, personal enhancement, dressing and undressing of upper and lower garments; b) household tasks such as arranging bed sheets, gardening and counting currency,Cognitive exercise for 20 minutes included loud reading, dual task activity (reading while walking, writing or drawing while listening music), solving picture puzzle, clay color activity, and neurobic exercise (for example brushing teeth with the non-dominant hand, Recreational activity for10 minutes included domestic duties, work, travel or specific treatment. These were balanced with recreational activity such as viewing television, playing indoor games, table games, quizzes, carom, Chinese checkers, telling story, singing, participating in organized social events.
10 session (70 minutes per session )of OTP held over 5 weeks
|
Comparator Agent |
STANDARD MEDICAL TREATMENT
|
Medication as prescribed and considered appropriate by a Geriatrician/Pschiatrist
Held over 5 weeks |
|
Inclusion Criteria
|
Age From |
60.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Both |
Details |
a)Diagnosed cases of Mild to Moderate dementia. The diagnosis be done by Guide or Co-guide.
b)Mini Mental State Examination MMSE ranging from 11 to 23.
c)Educational level of subjects is at least 5th standard, who can read and understand simple sentences.
|
|
ExclusionCriteria |
Details |
a)Severe Dementia patients.
b)Depression (Patients having GDS Score is more than 12)
c)Subjects having severe behavioral or psychological symptoms in dementia
d)Subjects require nursing care due to severe medical illness.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. Occupational Therapy clinical and Assessment form 2. Mini Mental Status Examination (MMSE)3.Hindi version of Geriatric Depression scale.4.Modified Physical Performance 5.Bristol Activities of Daily Living scale.6.BEHAV AD.Hindi version of WHOQOL-BREF
|
5 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
10/05/2011 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="3" Months="8" Days="30" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Dementia – problem statement The World Alzheimer’s
Report 2009, suggest there would be 35 million people worldwide with dementia
by 2010. That number is set to almost double every 20 years to 65.7 million in
2030 and 115.4 million in 2050. What’s worse, almost 60% of people with dementia
in 2010 will be from low and middle income countries like India, rising to
70.5% by 2050. This is a 10% increase over the earlier estimate made in 2005 -
meaning that the estimates made earlier for India will also increase. The
report had earlier said that by 2020, around 10 million Indians above the
age of 65 would suffer from dementia. By 2040, the number would increase to
around 22 million. WHO declare dementia a health priority, and countries
including India should develop a plan for dealing with the greater numbers of
dementia patients. Dementia refers to the
progressive decline of cognitive, social, and physical functioning due to
damage or disease of the brain beyond that of the normal aging process. Although
the exact epidemiological profile of dementias primarily Alzheimer’s Dementia
(AD) has not been established; various estimates indicate a virtual dementia
epidemic in India that needs urgent attention. Unfortunately-there is no
definite medical management to reverse the disease, rather rehabilitation
through occupational therapy, to improve-the quality of life (QOL) and functional status would be a sensible goal. Occupational therapy in
Dementia The need for developing
a comprehensive strategy to improve the quality of life of patients with
dementia in the community is not difficult to comprehend. In such a strategy,
concepts and interventions of occupational therapy need to be included as a
complement to standard drug therapy. The important steps in occupational
therapy intervention must include an awareness of the occupational identity,
and balance between self-care (the ability to look after oneself),
productivity (contribution to social and economic environments) and leisure
(the fulfillment and enjoyment of life).previous studies have found that there
is relationship between cognition on occupational participation and
performance. It is important that occupational therapists to develop
interventions in this areas. Occupational therapy interventions
often aim at supporting people with dementia to maintain an optimal level of
performance in the everyday occupations that they desire to do. Though
cognitive impairment is the primary disability in dementia, they also suffer
from others significant impairment related to the ageing process which affect
their autonomy and independence in basic, intermediate and advanced activities
of daily living; thereby affecting quality of life. Apart from this, family
members feel problem in accepting new role as a care giver and sometimes they
are unable to stimulate patient performing daily activities and feel helpless.
Disruptive behavior like wandering and aggressive behavior can put excessive
burden on caregiver, especially in terms of poor emotional health and quality
of life. The degree of behavioral problems in people with dementia causes
depression in caregivers and eventually they feel higher degree of burden. The
method of assessment used by a therapist is based on two patient centric
models: the model of human occupation and the Canadian model of
occupational performance, where as the interventions for cognitively impaired
patients is based on biomechanical and cognitive disability framework of
reference. Research Questions 1. Development of new
occupational therapy intervention for patients with dementia. 2. Whether the newly
developed occupational therapy intervention is effective for improving
physical, cognitive, social, behavior, functional, and psychological
domain in patients with dementia. Rationale of Study Unfortunately, drugs are not yet effective in improving the
symptoms of dementia, and non-pharmacological strategies are generally more
time consuming and not widely available. A systematic review found
non-pharmacological interventions to produce effect sizes in behavior similar
or larger to those seen with cholinesterase inhibitors, the currently available
drug treatment, but without any side effects. The primary focus of occupational
therapy was to improve patients’ ability to perform activities of daily living
and hence promote independence and participation in social activities and to
reduce the burden on the care giver and ultimately improve their quality of
life. Aims and Objectives 1. To develop a novel occupational
therapy program for mild-moderate dementia. 2. To study the
effectiveness of newly develop therapeutic regime on Physical, Functional,
social, behavior, Cognition and psychological health of dementia patients. 3. To improve the
productivity and quality of life of dementia patients. Hypothesis Novel occupational therapy program is effective in patients with
dementia.
|