Effectiveness of Home Modification on Falling, Occupational Performance and Life Habits in Elderly with Dementia
Design
a clinical trial with a control group; with parallel groups; one-way blinded; randomized;
Settings and conduct
Participants are randomly selected from the available samples referred to hospitals under the auspices of the University of Medical Sciences in Tehran. After obtaining written consent and completing a questionnaire of some demographic information, other questionnaires are filled out for the intervention. Then, after 1 month and 2 months of the intervention, the home adaptation is re-evaluated and the scores are recorded. Finally, after 3 months of the intervention, the questionnaires used as outcome measurement tools are used to determine the impact of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Elderly people 65 and older have symptoms of dementia and have been approved by a neurologist.
The level of dementia in the elderly is mild; (Dementia clinical rating test score is 4.5 to 9)
Elderly with dementia, stay at home.
Exclusion criteria:
The elderly with dementia lives in a nursing home or is bedridden.
The elderly have a history of other neurological problems, orthopedic and rheumatological disorders, acute psychiatric disorders based on the information in the medical record.
Intervention groups
Intervention:
home modification is performed as an intervention. Home modification is a set of strategies that include home improvement and renovation, the use of assistive devices, the use of visual cues and memory aids, the re-arrange or removal of furniture and household hazardous items, and the simplify of activities.
Control:
They are waiting in line to receive the intervention.
Main outcome variables
Fall; Occupational Performance; Life Habits; Home Modification
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210106049950N1
Registration date:2021-05-31, 1400/03/10
Registration timing:registered_while_recruiting
Last update:2021-05-31, 1400/03/10
Update count:0
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
Hamed Setoudeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 6497
Email address
h_setoudeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-12, 1399/10/23
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Home Modification on Falling, Occupational Performance and Life Habits in Elderly with Dementia
Public title
Effectiveness of Home Modification on Falling, Occupational Performance and Life Habits in Elderly with Dementia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly people 65 and older have symptoms of dementia and have been approved by a neurologist.
The level of dementia in the elderly is mild; (Clinical Dementia Rating (CDR) test score is 4.5 to 9)
Elderly with dementia, stay at home.
Exclusion criteria:
The elderly with dementia lives in a nursing home or is bedridden.
The elderly have a history of other neurological problems, orthopedic and rheumatological disorders, acute psychiatric disorders based on the information in the medical record.
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated into two groups using a permuted balanced block randomization method with the size of blocks 4 and 6. The random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of permuted balanced block randomization method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the statistical analyzer is blind and does not know about the assignment of individuals to groups and the data is provided to the analyzer in encrypted form.
Placebo
Not used
Assignment
Parallel
Other design features
p
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 52, Vesal Shirazi Ave., Keshavarz, Blvd., Tehran University Town
City
Tehran
Province
Tehran
Postal code
1417743855
Approval date
2020-12-27, 1399/10/07
Ethics committee reference number
IR.TUMS.FNM.REC.1399.163
Health conditions studied
1
Description of health condition studied
dementia
ICD-10 code
F01
ICD-10 code description
Vascular dementia
Primary outcomes
1
Description
Fall
Timepoint
before intervention, 30, 60 and 90 days after intervention
Method of measurement
Home Falls and Accidents Screening Tool (HOME FAST)
2
Description
Occupational Performance
Timepoint
before intervention and 90 days after intervention
Method of measurement
Canadian Occupational Performance Measure (COPM)
3
Description
Life Habits
Timepoint
before intervention and 90 days after intervention
Method of measurement
Life Habits questionnaire (Life-H)
4
Description
Home Modification
Timepoint
before the intervention and 30, 60 and 90 days after the intervention
Method of measurement
Home Falls and Accidents Screening Tool (HOME FAST)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: home modification. First, the demographic information questionnaire, the Canadian Occupational Performance Measure, and the Life Habits Questionnaire are completed for the participant. The home environment is then evaluated with Home Falls and Accidents Screening Tool. Then, for different environments of the house (kitchen, bathroom, stairs, ...) modification actions will be implemented if necessary. (Modifications actions for the intervention group include the following: 1. Modification for access, which includes; Doors, locks, handles, barriers, corridors, ramps, and bathroom modifications. 2. Check the edges of the stairs inside and outside the house 3. Check the condition of the floor coverings inside and outside the house, bathroom, and toilet 4. Check the floor surfaces for slipperiness 5. Check the floor coverings (carpet, rug, carpet, and padding) 6. Check the light access to the bedside lamp from bed 7. Check the brightness of outdoor paths, stairs, and entrances at night, which have enough light 8. Check the brightness of outdoor and indoor lights (Rooms, reception, hallway, bathroom, toilet, and kitchen) 9. Check the existence of non-slip floors for safe entry into the bathroom and bathtub and toilet 10. Check the installation of handles in the bathroom and next to the bathtub and shower 11. Check the direction Easy and safe access to the kitchen utensils 12. Check the railings of the inside and outside stairs of house 13. Check the safe access for pet care 14. Check the use of slippers and shoes that are perfectly suitable for the person's feet 15. Eliminate clutter and Indoor crowds 16. Check the required assistive devices 17. Check the arrangement of furniture and appliances 18. Use visual and auditory tips 19. Provide solutions to simplify activities)
Category
Rehabilitation
2
Description
Control group: control
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziaian Hospital
Full name of responsible person
Zahra Vahabi
Street address
20 meters from Abuzar, Abuzar Square, Qapan Crossroads, Qazvin St.
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6814
Email
ziaeian@tums.ac.ir
Web page address
https://ziaeian.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Dalvand
Street address
Department of Occupational Therapy, Tehran University of Medical Sciences, Faculty of Rehabilitation, Faculty of Rehabilitation, Enghelab St.
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 3939
Email
hdalvand@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Setoudeh
Position
Master of Science
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 52, Vesal Shirazi Ave., Keshavarz, Blvd., Tehran University Town
City
Tehran
Province
Tehran
Postal code
1417743855
Phone
+98 74 3333 6497
Fax
Email
h_setoudeh@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Setoudeh
Position
Master of Science
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 52, Vesal Shirazi Ave., Keshavarz, Blvd., Tehran University Town
City
Tehran
Province
Tehran
Postal code
1417743855
Phone
+98 74 3333 6497
Fax
Email
h_setoudeh@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Setoudeh
Position
Master of Science
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 52, Vesal Shirazi Ave., Keshavarz, Blvd., Tehran University Town
City
Tehran
Province
Tehran
Postal code
141774385
Phone
+98 917 662 1050
Email
h.setoudeh7@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available