DementiaNCT03576170
Investigate the Efficacy and Effectiveness of Aromatherapy for the Management of Behavioral and Psychological Symptoms of Dementia
A study testing aromatherapy in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
In recent decades, following an increased longevity in Hong Kong, there is a drastic increase in the prevalence chronic conditions, including dementia. Behavioral and psychological symptoms of dementia (BDSP) seem to be the main reasons of suffering for many older adults. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Nov 2017to 1 Oct 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years of age or older
- have a CMMSE score below 18 if illiterate, 19 if they have 1-2 years of education, and 20 if they had more than 2 years of education
- reported to have BPSD;
- willing to participate in the research, with informed consent signed by their guardian or carer.
Who cannot join
- allergic to essential oils
- refused to give consent
- over-sensitive to tactile stimulation
- have a history of kidney and liver disease
- have ever had an epileptic seizure.
Trial locations and contacts
1 site in 1 country.
About this study
In recent decades, following an increased longevity in Hong Kong, there is a drastic increase in the prevalence chronic conditions, including dementia. Behavioral and psychological symptoms of dementia (BDSP) seem to be the main reasons of suffering for many older adults. This condition does not only pose a burden to the whole family but also the healthcare system.
While conventional treatment of BPSD using pharmacotherapy and non-pharmacological treatments has been effective for managing symptoms, owing to the adverse side effects caused by anti-psychotic drugs and the short effective period incurred by non-pharmacological interventions, development of alternative and non-pharmacological approaches for the management of behavioral disturbances and pain is of urgent need. Research has shown that aromatherapy (both administered through inhalation and therapeutic massage) has been effective in reducing behavioral disturbances of dementia patients. These findings support the premise that aromatherapy and the investigators hope to provide further evidence to support the use of aromatherapy as an evidence-based mainstream intervention for reducing behavioral and psychological symptoms of dementia (BPSD).
Read more
Whilst there is sufficient evidence to support the effectiveness of aromatherapy, few studies compared the effectiveness of the use of aromatherapy by inhalation and/or therapeutic massage. The investigators aim to address the above research gaps on the clinical application of aromatherapy on BPSD, with a focus on comparing the differential effectiveness between administration by inhalation and administration by therapeutic massage. The proposed research aims to (1) test the efficacy and effectiveness of aromatherapy on the symptom management of BPSD in older adults; (2) compare the effects of aromatherapy-scent (i.e., inhalation) and aromatherapy-touch (i.e., therapeutic massage) in older adults with BPSD. This study also explores the benefits of aromatherapy on cognitive functioning, functional performance and social engagement as secondary outcomes.
A randomized, controlled, and single blinded trial is proposed. 120 older adults with BPSD will be randomly assigned to aroma inhalation (intervention), aroma-touch or wait-list (control) treatments. The primary outcomes measured are a caregiver-rated inventory of agitated behaviors and abnormalities of mood and psychotic phenomenal, cognitive functioning, functional performance and social engagement (secondary outcome) will be assessed three time points the study hypotheses are supported, the findings will provide empirical support for a treatment option that could improve psychological well-being and also improve cognitive functioning, functional performance, and social engagement of older adults.
- Conditions
- Dementia
- Being tested
- aromatherapy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromatherapyOther
aromatherapy by inhalation and/or therapeutic massage
| Study group | Role | What they receive |
|---|---|---|
| aromatherapy-scent | Active comparator | Not described Receives: Other: aromatherapy |
| aromatherapy-touch | Active comparator | Not described Receives: Other: aromatherapy |
| wait-list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese Version of the Cohen- Mansfield Agitation Inventory (CMAI)
It is a care-giver rated inventory to assess agitation in elderly persons and records the frequency of occurrence of BDSP at different period of time and thus can be used for assessing the changes among three times points (baseline, 2-months after intervention and after the completion of the intervention) in four months. It includes descriptions of 29 agitated behaviors, and each is rated on a 7-point scale of frequency. The total scores range from 29 points to 203 points, a higher score of CMAI indicates more frequent agitation behaviors.
Measured: baseline, 2-months after intervention and after the completion of the intervention in four months
Chinese Version of the Neuropsychiatric Inventory (NPI)
It is used to assess the changes of the abnormalities of mood and psychotic phenomena among three times points (baseline, 2-months after intervention and after the completion of the intervention) in four months. If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress) using a 5-point scale. The NPI-Q provides symptom Severity and Distress ratings for each symptom), and total Severity and Distress scores reflecting the sum of individual domain scores ranging from 0 to 36 and ranging from 0 to 60 respectively.
Measured: baseline, 2-months after intervention and after the completion of the intervention in four months
Secondary outcomes (3)
Cantonese Version of the Mini-mental State Examination (CMMSE)
Cantonese Version of Mini-mental State Examination (MMSE) is a brief 30-point questionnaire used to assess the change of the cognitive functions among three time points (baseline, 2-months after intervention and after the completion of the intervention) in four months. The range of the score is from 0 point to 30 points, which a lower score indicates the worse cognitive functions.
Measured: baseline, 2-months after intervention and after the completion of the intervention in four months
Chinese Version of the Barthel Index-100
Chinese Version of the Barthel Index-100 is used to measure the change of the performance in activities of daily living (ADL) among three time points (baseline, 2-months after intervention and after the completion of the intervention) in four months. Scores range from 0 to 100, with higher scores indicating greater independence.
of performance in basic activities of daily living (BADL) which is sensitive to either decline or improvement on the functional level of the elderly
Measured: baseline, 2-months after intervention and after the completion of the intervention in four months
Chinese Version of the Index of Social Engagement(ISE)
The change of the social engagement among three time points (baseline, 2-months after intervention and after the completion of the intervention) in four months will be measured using the 6-item index of social engagement (ISE). Total scores on the ISE can range from 0 to 6, with a higher score indicating a higher level of social engagement.
Measured: baseline, 2-months after intervention and after the completion of the intervention in four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start29 Nov 2017
- Primary completion20 Sep 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSANG Hector Wing-Hong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576170
- Sponsor's protocol ID
- P17-0203-1
- Status last verified
- Apr 2019
- First submitted
- 8 Jun 2018
- Last updated
- 1 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Efficacy and Effectiveness of Aromatherapy for the Management of Behavioral and Psychological Symptoms of Dementia
- ClinicalTrials.gov ID
- NCT03576170
- Acronym / sponsor ID
- P17-0203-1
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 3 Jul 2018 (actual)
- 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.
In recent decades, following an increased longevity in Hong Kong, there is a drastic increase in the prevalence chronic conditions, including dementia. Behavioral and psychological symptoms of dementia (BDSP) seem to be the main reasons of suffering for many older adults. This condition does not only pose a burden to the whole family but also the healthcare system.
While conventional treatment of BPSD using pharmacotherapy and non-pharmacological treatments has been effective for managing symptoms, owing to the adverse side effects caused by anti-psychotic drugs and the short effective period incurred by non-pharmacological interventions, development of alternative and non-pharmacological approaches for the management of behavioral disturbances and pain is of urgent need. Research has shown that aromatherapy (both administered through inhalation and therapeutic massage) has been effective in reducing behavioral disturbances of dementia patients. These findings support the premise that aromatherapy and the investigators hope to provide further evidence to support the use of aromatherapy as an evidence-based mainstream intervention for reducing behavioral and psychological symptoms of dementia (BPSD).
Whilst there is sufficient evidence to support the effectiveness of aromatherapy, few studies compared the effectiveness of the use of aromatherapy by inhalation and/or therapeutic massage. The investigators aim to address the above research gaps on the clinical application of aromatherapy on BPSD, with a focus on comparing the differential effectiveness between administration by inhalation and administration by therapeutic massage. The proposed research aims to (1) test the efficacy and effectiveness of aromatherapy on the symptom management of BPSD in older adults; (2) compare the effects of aromatherapy-scent (i.e., inhalation) and aromatherapy-touch (i.e., therapeutic massage) in older adults with BPSD. This study also explores the benefits of aromatherapy on cognitive functioning, functional performance and social engagement as secondary outcomes.
A randomized, controlled, and single blinded trial is proposed. 120 older adults with BPSD will be randomly assigned to aroma inhalation (intervention), aroma-touch or wait-list (control) treatments. The primary outcomes measured are a caregiver-rated inventory of agitated behaviors and abnormalities of mood and psychotic phenomenal, cognitive functioning, functional performance and social engagement (secondary outcome) will be assessed three time points the study hypotheses are supported, the findings will provide empirical support for a treatment option that could improve psychological well-being and also improve cognitive functioning, functional performance, and social engagement of older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aromatherapy-scent | Active comparator | Other: aromatherapy |
| aromatherapy-touch | Active comparator | Other: aromatherapy |
| wait-list control | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 years of age or older
- have a CMMSE score below 18 if illiterate, 19 if they have 1-2 years of education, and 20 if they had more than 2 years of education
- reported to have BPSD;
- willing to participate in the research, with informed consent signed by their guardian or carer.
Key exclusion criteria (5 listed)
- allergic to essential oils
- refused to give consent
- over-sensitive to tactile stimulation
- have a history of kidney and liver disease
- have ever had an epileptic seizure.
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 |
|---|---|---|
| aromatherapyaromatherapy by inhalation and/or therapeutic massage | Other | aromatherapy-scent, aromatherapy-touch |
Primary outcome
Chinese Version of the Cohen- Mansfield Agitation Inventory (CMAI)
Time frame: baseline, 2-months after intervention and after the completion of the intervention in four months
It is a care-giver rated inventory to assess agitation in elderly persons and records the frequency of occurrence of BDSP at different period of time and thus can be used for assessing the changes among three times points (baseline, 2-months after intervention and after the completion of the intervention) in four months. It includes descriptions of 29 agitated behaviors, and each is rated on a 7-point scale of frequency. The total scores range from 29 points to 203 points, a higher score of CMAI indicates more frequent agitation behaviors.
Chinese Version of the Neuropsychiatric Inventory (NPI)
Time frame: baseline, 2-months after intervention and after the completion of the intervention in four months
It is used to assess the changes of the abnormalities of mood and psychotic phenomena among three times points (baseline, 2-months after intervention and after the completion of the intervention) in four months. If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress) using a 5-point scale. The NPI-Q provides symptom Severity and Distress ratings for each symptom), and total Severity and Distress scores reflecting the sum of individual domain scores ranging from 0 to 36 and ranging from 0 to 60 respectively.
3 secondary outcomes
Cantonese Version of the Mini-mental State Examination (CMMSE)
Time frame: baseline, 2-months after intervention and after the completion of the intervention in four months
Chinese Version of the Barthel Index-100
Time frame: baseline, 2-months after intervention and after the completion of the intervention in four months
Chinese Version of the Index of Social Engagement(ISE)
Time frame: baseline, 2-months after intervention and after the completion of the intervention in four months
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 1 May 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aromatherapy in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 5 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 1 May 2019. 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 Hong Kong. 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?
Chinese Version of the Cohen- Mansfield Agitation Inventory (CMAI) (time frame: baseline, 2-months after intervention and after the completion of the intervention in four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2019.