DementiaNCT02126059
Complementary Interventions on Patients With Dementia: Comparative and Longitudinal Research
A study testing Reminiscence, Cognitive stimulation and Aroma-massage in people with Dementia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Reminiscence, Cognitive stimulation and Aroma-massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- no hospitalization within the past two weeks
- not under severe acute illness
- no psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Reminiscence, Cognitive stimulation, Aroma-massage
- Keywords
- dementia, behavioral and psychological symptoms, quality of life
- Medical subject headings
- Dementia, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReminiscenceBehavioural
Also called Reminiscence complementary therapy
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.
Cognitive stimulationBehavioural
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.
Aroma-massageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive stimulation | Experimental | One cognitive stimulation session per week for a continuous 10 weeks, each session contains 50 minutes, totally 10 session topics related to cognitive stimulation. Receives: Behavioral: Reminiscence |
| Aroma-massage | Experimental | One hand and shoulder massage session per week for a continuous 10 weeks, each session contains 30 minutes, totally 10 session massage. Receives: Behavioral: Cognitive stimulation |
| reminiscence | Experimental | One reminiscence session per week for a continuous 10 weeks, each session contains 50 minutes, totally 10 session topics related to reminiscence. Receives: Behavioral: Aroma-massage |
| Control | No intervention | Control group remain regular activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Jing-Jy Wang, PhD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126059
- Sponsor's protocol ID
- Sellin127
- Status last verified
- Feb 2016
- First submitted
- 21 Apr 2014
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32813272
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02126059
- Acronym / sponsor ID
- Sellin127
- Conditions
- Dementia
- Keywords
- dementia, behavioral and psychological symptoms, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive stimulation | Experimental | Behavioral: ReminiscenceOne cognitive stimulation session per week for a continuous 10 weeks, each session contains 50 minutes, totally 10 session topics related to cognitive stimulation. |
| Aroma-massage | Experimental | Behavioral: Cognitive stimulationOne hand and shoulder massage session per week for a continuous 10 weeks, each session contains 30 minutes, totally 10 session massage. |
| reminiscence | Experimental | Behavioral: Aroma-massageOne reminiscence session per week for a continuous 10 weeks, each session contains 50 minutes, totally 10 session topics related to reminiscence. |
| Control | No intervention | –Control group remain regular activities |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- no hospitalization within the past two weeks
- not under severe acute illness
- no psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReminiscenceAlso: Reminiscence complementary therapyThe 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. | Behavioural | Cognitive stimulation |
| Cognitive stimulationThe 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. | Behavioural | Aroma-massage |
| Aroma-massageResearcher 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. | Behavioural | reminiscence |
Primary outcome
behavioral and psychological symptoms of dementia
Time frame: 2 years
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.
1 secondary outcome
quality of life
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Derived from this study: PubMed 32813272Ball 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing-Jy Wang, PhD principal investigator
National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminiscence, Cognitive stimulation and Aroma-massage in people with Dementia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
behavioral and psychological symptoms of dementia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02126059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.