DementiaNCT05009147
Home-based Massage by Caregivers for Dementia
A study testing Home-based massage by caregivers for dementia in people with Dementia and Massage, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the effects of manual massage on improving behavioral and psychological symptoms of dementia and sense of burden among caregivers. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Home-based massage by caregivers for dementia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 31 May 2022
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Over 65 years old, diagnosed with dementia, agitation or depression, irregular massage and exercise habits.
Who cannot join
- Those who have open wounds, inflammation, infection, burns and scalds, artificial blood vessels in the hands, or diagnosed as inappropriate for massage in the near future, the severity of symptoms affects the study participants.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taipei University of Nursing and Health Sciences
Taipei, 11219
Chen-Yi Song, 886-2-28227101 ext. 6136, cysong@ntunhs.edu.tw
About this study
Official title: Effects of Manual Massage on Improving Behavioral and Psychological Symptoms of Dementia and Sense of Burden Among Caregivers
The purpose of this study is to investigate the effects of manual massage on improving behavioral and psychological symptoms of dementia and sense of burden among caregivers.
Read the detailed description
A total of 40 patients with dementia and their family caregivers will be included and randomly allocated to experiment (n=20) or control group (n=20). The experiment and control group will receive whole body manual massage and placebo intervention (30 minutes once per week for 8 continuous weeks), respectively.
- Being tested
- Home-based massage by caregivers for dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based massage by caregivers for dementiaOther
A total of 40 patients with dementia and their family caregivers will be included and randomly allocated to experiment (n=20) or control group (n=20). The experiment and control group will receive whole body manual massage and placebo intervention (30 minutes once per week for 8 continuous weeks), respectively.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | receive whole body manual massage Receives: Other: Home-based massage by caregivers for dementia |
| control group | No intervention | After experiment, receive whole body manual massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
change agitation
Cohen-Mansfield Agitation Inventory (CMAI)
Measured: before , during and after 8-weeks massage training interventions
change depression
Cornell Scale for Depression in Dementia (CSDD)
Measured: before , during and after 8-weeks massage training interventions
change stress
Perceived Stress Scale(PSS)
Measured: before , during and after 8-weeks massage training interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Jan 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CY Song, National Taipei University of Nursing and Health Sciences
- Investigators
- Chen-Yi Song, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009147
- Sponsor's protocol ID
- CTH-109-2-5-025
- Status last verified
- Apr 2022
- First submitted
- 8 Aug 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Massage on Improving Behavioral and Psychological Symptoms of Dementia and Sense of Burden Among Caregivers
- ClinicalTrials.gov ID
- NCT05009147
- Acronym / sponsor ID
- CTH-109-2-5-025
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 17 Aug 2021 (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.
The purpose of this study is to investigate the effects of manual massage on improving behavioral and psychological symptoms of dementia and sense of burden among caregivers.
Detailed description
A total of 40 patients with dementia and their family caregivers will be included and randomly allocated to experiment (n=20) or control group (n=20). The experiment and control group will receive whole body manual massage and placebo intervention (30 minutes once per week for 8 continuous weeks), respectively.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Home-based massage by caregivers for dementiareceive whole body manual massage |
| control group | No intervention | –After experiment, receive whole body manual massage |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Over 65 years old, diagnosed with dementia, agitation or depression, irregular massage and exercise habits.
Key exclusion criteria (1 listed)
- Those who have open wounds, inflammation, infection, burns and scalds, artificial blood vessels in the hands, or diagnosed as inappropriate for massage in the near future, the severity of symptoms affects the study participants.
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 |
|---|---|---|
| Home-based massage by caregivers for dementiaA total of 40 patients with dementia and their family caregivers will be included and randomly allocated to experiment (n=20) or control group (n=20). The experiment and control group will receive whole body manual massage and placebo intervention (30 minutes once per week for 8 continuous weeks), respectively. | Other | experimental group |
Primary outcome
change agitation
Time frame: before , during and after 8-weeks massage training interventions
Cohen-Mansfield Agitation Inventory (CMAI)
change depression
Time frame: before , during and after 8-weeks massage training interventions
Cornell Scale for Depression in Dementia (CSDD)
change stress
Time frame: before , during and after 8-weeks massage training interventions
Perceived Stress Scale(PSS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Chen-Yi Song principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based massage by caregivers for dementia in people with Dementia and Massage, run by National Taipei University of Nursing and Health Sciences 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen-Yi Song (886-2-28227101 ext. 6136, cysong@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change agitation (time frame: before , during and after 8-weeks massage training interventions). The study lists 3 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 7 Apr 2022.