Evaluation of the effectiveness of occupational therapy technology added to drug therapy compared to drug therapy alone among elderly people with dementia and their caregivers
1. Determine the effectiveness of occupational therapy in the elderly with dementia and their caregivers
2. Determine the cost-effectiveness (economic evaluation) of occupational therapy in the elderly with dementia
Design
Clinical trial with control group, triple blind, randomized (blocks of size 4).
100 patients were divided into four intervention and control groups and received intervention between August and October 2019.
Settings and conduct
After randomization and assignment of patients in each group, the elderly with dementia received a 12-week occupational therapy intervention (2 sessions 1 hour per week) at home.
Caregivers also received 12 weeks of intervention and occupational therapy counseling at home and at the Brain & Cognitive or Yas Clinic in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 65 and older; Neurologist's diagnosis based on DSM-IV criteria for dementia. Non-inclusion criteria:
Relatively severe and severe dementia; The patient's unwillingness and cooperation to intervene
Intervention groups
Intervention group 1: Elderly patients with dementia who receive occupational therapy with drug therapy.
Control group 1: Elderly patients with dementia who receive only medication.
Intervention group 2: Caregivers of demented elderly who receive occupational therapy interventions and counseling.
Control group 2: caregivers of demented elderly who do not receive occupational therapy interventions and counseling.
Main outcome variables
Patients: Patient Recognition Rate (ACE-R), Mini Mental State Examination score, Patient Balance Test (BERG) score.
Caregivers: Depression, Anxiety, Caregiver burden, Life Balance Inventory, Loneliness Management Social and Emotional Adult (SALSA) and Time Management
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191027045253N1
Registration date:2020-05-01, 1399/02/12
Registration timing:retrospective
Last update:2020-05-01, 1399/02/12
Update count:0
Registration date
2020-05-01, 1399/02/12
Registrant information
Name
Marjan Ghandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3374 4307
Email address
m.ghandi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-09-20, 1398/06/29
Actual recruitment start date
2019-10-06, 1398/07/14
Actual recruitment end date
2019-11-05, 1398/08/14
Trial completion date
2019-12-20, 1398/09/29
Scientific title
Evaluation of the effectiveness of occupational therapy technology added to drug therapy compared to drug therapy alone among elderly people with dementia and their caregivers
Public title
Effectiveness of occupational therapy in dementia patients and their caregivers
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 65 years
Neurologist's diagnosis based on DSM-IV criteria for dementia
Patients should be kept at home by official carers
Exclusion criteria:
Relatively severe and severe dementia
Patient's unwillingness and no cooperation to intervene
Age
From 65 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
120
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to the intervention (12 sessions of home therapy over 6 weeks) and control group (routine care without any occupational therapy), using the randomized block design (block of size four).
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants were divided into two groups: Group I and II: Elderly with Dementia and Control and Group III and IV: Informal caregivers of patients with Dementia and Control.
Group I and II: Dementia Patients: Due to the intervention at home and pre and post tests at home, subjects were blinded to the intervention or control group.
Group 3 and 4: Unofficial caregivers of dementia: Although pre and post tests were performed in the clinic and of course occupational therapy was also performed at home for the group, the subjects were blinded to what group they were in and They didn't know which group they were in.
Occupational Therapy Intervention Providers: Given that pre and post-patient testing was performed by someone else, and we have used 4 different occupational therapists to intervene in this study, the intervention providers provided information on the patient's status at which stage of the disease were uninformed and did only the intervention and remained blind until after the analysis of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-10-08, 1398/07/16
Ethics committee reference number
IR.KMU.REC.1398.329
Health conditions studied
1
Description of health condition studied
Dementia
ICD-10 code
F03.90
ICD-10 code description
Unspecified dementia without behavioral disturbance
Primary outcomes
1
Description
Patient's cognition
Timepoint
Before the intervention and 6 weeks after the start of occupational therapy
Method of measurement
Addenbrooke ҆s Cognitive Examination
2
Description
Cognitive evaluation of patients
Timepoint
Before the intervention and 6 weeks after the start of occupational therapy
Method of measurement
Mini-Mental State Examination
3
Description
Patient Balance
Timepoint
Before the intervention and 6 weeks after the start of occupational therapy
Method of measurement
BERG Balance Scale
4
Description
Depression in patients with dementia
Timepoint
Before the intervention and 6 weeks after the start of occupational therapy
Method of measurement
Beck Depression Inventory ii
5
Description
Anxiety in caregivers of patients with dementia
Timepoint
Before the intervention and 6 weeks after the start of occupational therapy
Method of measurement
Beck Anxiety Inventory
6
Description
Caregiver Burden
Timepoint
Before the intervention and 6 weeks after the start of occupational therapy
Method of measurement
Caregiver Burden
7
Description
The life balance structure of caregivers
Timepoint
Before the intervention and 6 weeks after the start of occupational therapy
Method of measurement
Life Balance Inventory
8
Description
Social and emotional loneliness of caregivers
Timepoint
Before the intervention and 6 weeks after the start of occupational therapy
Method of measurement
Social and Emotional Loneliness Scale for Adults
9
Description
Time management of caregivers
Timepoint
Before the intervention and 6 weeks after the start of occupational therapy
Method of measurement
Time Management Questionnaire
Secondary outcomes
1
Description
Social skills
Timepoint
Before the intervention and 6 weeks after the start of occupational therapy
Method of measurement
Disability Assessment For Dementia
2
Description
Motor Abilities
Timepoint
Before the intervention and 6 weeks after the start of occupational therapy
Method of measurement
Timed “Up & Go” (TUG), Ten Meter , Chairstand, Barthel , Allen
3
Description
Quality of Life
Timepoint
Before the intervention and 6 weeks after the start of occupational therapy
Method of measurement
Euro Qol- 5 Dimension (in patients) AND World Health Organization Quality of Life-BREF (in Caregivers)
Intervention groups
1
Description
Intervention group 1: Elderly with dementia to reduce cognitive impairment and increase motor skills for 6 weeks (12 one-hour sessions, 2 times a week) by occupational therapist, occupational therapy intervention to enhance cognitive skills, enhance daily life skills, they received reinforcement and facilitation of motor skills at home.
Category
Rehabilitation
2
Description
Control group 1: Elderly patients with dementia who received only medication.This group performed the relevant tests (before) and was again taken after 6 weeks of testing.
Category
N/A
3
Description
Intervention group 2: Informal caregivers received 12 sessions of occupational therapy on how to treat patients with dementia and raise awareness about the cause of patients' behavioral problems and provide adaptive strategies to better perform the caregiver role and also to restore caregiver balance. These 12 sessions were performed as the first 5 sessions in the clinic, 2 sessions at the patient's home, 4 sessions via telephone counseling and the last session again in the clinic.
Category
Rehabilitation
4
Description
Control group 2: caregivers of patients with dementia who did not receive any intervention.