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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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    
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.

 

 
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