UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041505 |
|---|---|
| Receipt number | R000047336 |
| Scientific Title | The Effects of Hand Massage on Agitated Behaviors of Elderly People with Dementia: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2020/08/21 |
| Last modified on | 2023/08/24 15:02:42 |
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Basic information
Public title
The Effects of Hand Massage on Agitated Behaviors of Elderly People with Dementia: A Randomized Controlled Trial
Acronym
The Effects of Hand Massage on Agitated Behaviors of Elderly People with Dementia
Scientific Title
The Effects of Hand Massage on Agitated Behaviors of Elderly People with Dementia: A Randomized Controlled Trial
Scientific Title:Acronym
The Effects of Hand Massage on Agitated Behaviors of Elderly People with Dementia
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effect during a given intervention period on agitated behaviors of elderly people with dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from the baseline by the Japanese version of the Cohen-Mansfield Agitation Inventory scores after 2-week intervention
Key secondary outcomes
Total sleep time, Sleep efficiency, Sleep latency, Wake after sleep onset
core symptoms of dementia, health condition (diet, excretion, activity, etc.), Events such as falls
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention
Hand massage before nighttime sleep for about 10 minutes, 6 times in 2 weeks
Interventions/Control_2
Control
Usual care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Dementia or taking anti-dementia drugs, documented to have core symptoms of dementia or symptoms of BPSD
2. Agitation (CMAI total scores 32/154 or more points)
3. More than 3 months in the facility
Key exclusion criteria
1. In case they have health problems such as injuries or bruises on skin from the joints of both hands to the periphery.
2. In case they started taking psychotropic drugs or changed the type and amount within the past 3 months.
3. In case they have an acute illness under treatment.
4. In case they resist being touched (Including significant confusion due to delirium, etc.)
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Yamamoto |
Organization
Japanese Red Cross Hiroshima College of Nursing
Division name
Gerontological Nursing
Zip code
738-0052
Address
1-2 Ajinadai-Higashi Hatsukaichi-shi Hiroshima
TEL
0829-20-2800
yamamoto@jrchcn.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Yamamoto |
Organization
Japanese Red Cross Hiroshima College of Nursing
Division name
Gerontological Nursing
Zip code
738-0052
Address
1-2 Ajinadai-Higashi Hatsukaichi-shi Hiroshima
TEL
0829-20-2800
Homepage URL
yamamoto@jrchcn.ac.jp
Sponsor or person
Institute
Japanese Red Cross Academy
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Japanese Red Cross Hiroshima College of Nursing
Address
1-2 Ajinadai-Higashi Hatsukaichi-shi Hiroshima
Tel
0829-20-2800
rinri@jrchcn.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047336
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
