Back to resultsComplementary Interventions on Patients With Dementia: Comparative and Longitudinal Research
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Reminiscence
Cognitive stimulation
Aroma-massage
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring dementia, behavioral and psychological symptoms, quality of life
Eligibility Criteria
Inclusion Criteria:
- been diagnosed with dementia (all stages) or MMSE below 23 for high school educated and 17 for less than high school education
- able to communicate verbally or nonverbally
- able to understand short sentences
- can sit for at least 50 mins.
Exclusion Criteria:
- no hospitalization within the past two weeks
- not under severe acute illness
- no psychiatric disorders.
Sites / Locations
- National Cheng Kung University Dementia center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Cognitive stimulation
Aroma-massage
reminiscence
Control
Arm Description
One cognitive stimulation session per week for a continuous 10 weeks, each session contains 50 minutes, totally 10 session topics related to cognitive stimulation.
One hand and shoulder massage session per week for a continuous 10 weeks, each session contains 30 minutes, totally 10 session massage.
One reminiscence session per week for a continuous 10 weeks, each session contains 50 minutes, totally 10 session topics related to reminiscence.
Control group remain regular activities
Outcomes
Primary Outcome Measures
behavioral and psychological symptoms of dementia
To examine if patients' behavioral and psychological symptoms decrease after the intervention.
Chinese version of Cohen-Mansfield Agitation Inventory (CMAI) will be used to measure this outcome.
Data will be analyzed through GLM repeated measure-GEE.
Secondary Outcome Measures
quality of life
To examine if patients' quality of life improve after the intervention. WHO Quality of Life-brief Taiwanese version (WHOQOL-BREF) will be used to measure this outcome.
Data will be analyzed through GLM-repeated measure-GEE.
Full Information
NCT ID
NCT02126059
First Posted
April 21, 2014
Last Updated
February 14, 2016
Sponsor
National Cheng-Kung University Hospital
Collaborators
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02126059
Brief Title
Complementary Interventions on Patients With Dementia: Comparative and Longitudinal Research
Official Title
The Health Effects of Cognitive Stimulation, Reminiscence, and Aroma-massage Complementary Interventions on Different Behavior Patterns of Patients With Dementia: Comparative and Longitudinal Research
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
National Science Council, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cognitive function, behavioral and psychological symptoms, and quality of life will improve after administration of cognitive stimulation therapy, reminiscence therapy, and aroma-massage therapy in patients with dementia.
Detailed Description
This study will base on the pattern of behavioral and psychological symptoms of dementia, to verify and compare the effectiveness of the three non-pharmacological complementary interventions, cognitive stimulation therapy, reminiscence therapy, and aroma-massage therapy on patients' cognitive function, behavior and psychological symptoms, and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
dementia, behavioral and psychological symptoms, quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive stimulation
Arm Type
Experimental
Arm Description
One cognitive stimulation session per week for a continuous 10 weeks, each session contains 50 minutes, totally 10 session topics related to cognitive stimulation.
Arm Title
Aroma-massage
Arm Type
Experimental
Arm Description
One hand and shoulder massage session per week for a continuous 10 weeks, each session contains 30 minutes, totally 10 session massage.
Arm Title
reminiscence
Arm Type
Experimental
Arm Description
One reminiscence session per week for a continuous 10 weeks, each session contains 50 minutes, totally 10 session topics related to reminiscence.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group remain regular activities
Intervention Type
Behavioral
Intervention Name(s)
Reminiscence
Other Intervention Name(s)
Reminiscence complementary therapy
Intervention Description
The 10 session topics include "Happy to seeing you", "Childhood stories", "Food flavor", "Our old songs", "Festival", "My family", "My Carrier", "Unforgettable events", "My home", and "My award".
small group intervention (8-12 per group), expected total number of group is 5.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive stimulation
Intervention Description
The 10 session topics include "psycial activities", "sound", "face", "food", "word association", "number and games", "being creative", "categorizing objects", "orientation", and "team qiuz".
small group intervention (8-12 per group), total number of group is 5.
Intervention Type
Behavioral
Intervention Name(s)
Aroma-massage
Intervention Description
Researcher will conduct hand and arm massage to a patient, once a week, each time session for 30 mins with natural tested and safe aroma-essential oil.
Primary Outcome Measure Information:
Title
behavioral and psychological symptoms of dementia
Description
To examine if patients' behavioral and psychological symptoms decrease after the intervention.
Chinese version of Cohen-Mansfield Agitation Inventory (CMAI) will be used to measure this outcome.
Data will be analyzed through GLM repeated measure-GEE.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
quality of life
Description
To examine if patients' quality of life improve after the intervention. WHO Quality of Life-brief Taiwanese version (WHOQOL-BREF) will be used to measure this outcome.
Data will be analyzed through GLM-repeated measure-GEE.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
been diagnosed with dementia (all stages) or MMSE below 23 for high school educated and 17 for less than high school education
able to communicate verbally or nonverbally
able to understand short sentences
can sit for at least 50 mins.
Exclusion Criteria:
no hospitalization within the past two weeks
not under severe acute illness
no psychiatric disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-Jy Wang, PhD
Organizational Affiliation
National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Dementia center
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
32813272
Citation
Ball EL, Owen-Booth B, Gray A, Shenkin SD, Hewitt J, McCleery J. Aromatherapy for dementia. Cochrane Database Syst Rev. 2020 Aug 19;8(8):CD003150. doi: 10.1002/14651858.CD003150.pub3.
Results Reference
derived
Learn more about this trial
Complementary Interventions on Patients With Dementia: Comparative and Longitudinal Research
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