DementiaNCT03575026
Effectiveness-Implementation Cluster RCT to Improve Community-dwelling Early Dementia Patients by Music Intervention
A study testing Music-with-movement in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This is a 12-week cluster randomized controlled trial utilizing music-with-movement (MWM) intervention compared with usual care to investigate the effect of MWM among subjects with early dementia or mild cognitive impairment implemented by their caregivers at home. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Music-with-movement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Apr 2018to 31 Jul 2019
- 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
- Aged 60 or above
- Cognitively impaired, defined by Global Deterioration Scale 3 or 4
- Community-dwelling
- With stable medical condition
- Able to communicate in Cantonese
- have a family caregiver who was willing to take part in the study
- Primary caregiver of the PWeD
- Related to the PWeD and not a paid live-in care attendant
Who cannot join
- Suffering from any critical medical or psychiatric illnesses
- Unable to hear even using hearing aids
- Unable to sit independently for around 30 minutes
- Received music intervention within 6 months
- Participate in any clinical trial within 6 months prior to the start of study
- Caregivers
- Suffering from any critical medical or psychiatric illnesses
- Received music intervention within 6 months prior to the start of study
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: Partnership With the Community to Improve the Well-being of People With Mild Cognitive Impairment (MCI)/Early Dementia and Their Caregivers With Music Intervention: an Effectiveness-Implementation Cluster Randomized Clinical Hybrid Trial
This is a 12-week cluster randomized controlled trial utilizing music-with-movement (MWM) intervention compared with usual care to investigate the effect of MWM among subjects with early dementia or mild cognitive impairment implemented by their caregivers at home.
Read the detailed description
Dementia is a neurodegenerative disorder and it can adversely affect patient's cognitive, behavioural, social and emotional functioning. Its prevalence will increase continuously because of the increase in aging population and it is predicted that around 333,000 people in Hong Kong (equivalent to 11% population aged 60 or above) will suffer from dementia in year 2039. The gradual functional decline, communication difficulties, the behavioural symptoms associated with cognitive impairment, may affect the relationships with the family members and the wellbeing. A latest Cochrane Review commented that music-based intervention may be helpful to improve emotional wellbeing and quality of life according to some limited evidences, as well as depressive symptoms, although future studies with larger sample sizes and more rigorous research design are suggested
In 2014 - 2016, our team has modified a music-with-movement intervention designed for nursing home residents with moderate dementia, into a protocol specified for caregiver-delivered home-based intervention to promote the psychosocial wellbeing of people with early dementia in Hong Kong. We found that the dyadic music-with-movement intervention yielded significant reduction on anxiety levels of people with early dementia as compared to control group. Similar, Särkämö and colleagues also found that caregiver-implemented music intervention group have reduced depression of people with early dementia and reduced caregiver burden. With the strong evidence that music intervention is useful in improving the wellbeing of people with early dementia and their family caregiver, it is essential to disseminate the culture-appropriated and validated intervention for promoting health and evaluate its effectiveness in real-practice setting by implementation research.
This research is anchored by a conceptual framework of leisure and subjective wellbeing. This framework explained that through participating in activities outside the obligated works (either paid or unpaid) that is subjectively regarded as leisure, would lead to an improvement of well-being through five psychological mechanisms, namely detachment-relaxation, autonomy, mastery, meaning and affiliation. Caregivers and care-recipients are found relaxed after participating in music intervention because they are temporary detached from the everyday caregiving chaos. Participating in an intervention designed by the participants themselves would increase their sense of autonomy and mastery. During the dyadic music intervention, the caregivers and people with MCI/early dementia would design their activities within the music-with-movement framework after instruction of music therapist that allow them to exercise their choices based on their music preference. Through the interaction in the dyadic intervention, it has been found that through participating in dyadic music intervention, people with dementia and their caregivers have improved in relationship and social inclusiveness. Caregivers would feel their competence or mastery in the skills when leading music intervention. Staff and caregivers reported that activities that address the psychological needs, provide enjoyment, value individuality, reinforce a sense of identity and belonging are meaningful to people with dementia. Therefore, we hypothesized that dyadic music-with-movement intervention would improve the subjective wellbeing of both the people with MCI/early dementia and their caregiver, if there are relevant implementation strategies to increase the ease of uptake of the intervention. For example, stress of caregivers could be relieved by successful music intervention.
When the aim is to maximize the uptake of the intervention in the real-life settings as a routine, we have to examine the influence of contextual factors on implementation. Hence, this study have three main objectives:
- To test the effectiveness of the dyadic music-with-movement intervention on wellbeing of people with MCI/early dementia, and of their caregivers in real-life settings;
- To conduct a process evaluation of the effectiveness-implementation study by gathering information on the implementation process; and
- To validate and extend the applicability of "Leisure \& Wellbeing" conceptual framework to the dyads. In this project, one of the implementation strategies to maximize the uptake of the music intervention by the dyads, is to train a team volunteers to support the caregivers and people with MCI/early dementia, which is a unique group of population. There is a general lack of knowledge and inappropriate attitude towards dementia or Alzheimer's disease worldwide. In Hong Kong, it was reported that university students majoring in medicine, nursing, occupational therapy and social work showed inadequate knowledge towards this group of patients. By providing training for volunteers to support participating dyads, it would be able to provide a better understanding on dementia and create a supportive community for dementia. Therefore, we will explore the changes in the following outcomes of the volunteers:
- To examine the change of knowledge and attitudes towards dementia of the volunteers before and after participating in the project; and
- To examine the change of satisfaction and motivation to volunteering before and after participating in the project.
- Conditions
- Dementia
- Being tested
- Music-with-movement, Usual care
- Keywords
- Early dementia, Caregiver, Anxiety, Well-being
- Medical subject headings
- Dementia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-with-movementBehavioural
Subjects will listen their preferred music and move their body actively with music
Usual careBehavioural
Social activity acts as control with similar dose and intensity with intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects will receive 12-week music-with-movement intervention at home by their trained caregivers for 12 weeks, at least 3 sessions per week and 30 minutes for each session. Receives: Behavioral: Music-with-movement |
| Wait-list control | Placebo comparator | Subjects will receive 12-week usual care (social activity) at home. Dose is similar to intervention arm. After the completion of 12-week usual care, subjects will receive the same music intervention as intervention arm. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patients' anxiety
Rating Anxiety in Dementia (RAID), total score (range 0-54), higher indicates higher anxiety level (score>=11 indicates clinically significant anxiety)
Measured: Baseline, immediate post-intervention (month 3)
Changes in patients' depression
Cornell scale for depression in dementia (CSDD), total score (range 0-36), higher indicates higher depression
Measured: Baseline, immediate post-intervention (month 3)
Changes in caregivers' stress and well-being
Perceived Stress Scale 10 (PSS-10), total score (range 0-40), higher indicates higher perceived stress
Measured: Baseline, immediate post-intervention (month 3)
Changes in caregivers' stress
Heart Rate Variability (HRV)
Measured: Baseline, immediate post-intervention (month 3)
Changes in caregivers' well-being
Positive Aspects of Caregiving scale (PAC), total score (range 0-44), higher indicates more gain from caregiving experience
Measured: Baseline, immediate post-intervention (month 3)
Changes in caregivers' relationship with PWD
Quality of the Caregiver-Care Recipient Relationship, 4 questions (range 0-4 each), higher score indicates better relationship between caregiver and care recipient
Measured: Baseline, immediate post-intervention (month 3)
Secondary outcomes (4)
Changes in volunteers' satisfaction from volunteering
Volunteer Satisfaction Index (VSI), 3 sub-scores (Relationship within organization [range 0-70], Personal gain [range 0-70], Relationship with peers [range 0-28]). In any sub-score, higher mean better satisfaction in that aspect
Measured: Baseline, 3-month post-intervention (month 6)
Changes in volunteers' expectation from volunteering
Volunteer Functions Inventory (VFI), 6 sub-scores (Protective [range 0-35], Values [range 0-35], Career [range 0-35], Social [range 0-35], Understanding [range 0-35], Enhancement [range 0-35]). In each sub-score, higher score indicates that aspect motivates more that individual to be a volunteer.
Measured: Baseline, 3-month post-intervention (month 6)
Changes in volunteers' knowledge towards dementia
Alzheimer's Disease Knowledge Scale (ADKS), total score (range 0-24), higher indicates better knowledge towards Alzheimer's Disease
Measured: Baseline, 3-month post-intervention (month 6)
Changes in volunteers' attitude towards dementia
Dementia Attitude Scale (DAS), total score [calculated by summation of 2 sub-scores, range 0-140] and 2 sub-scores (Comfort [range 0-70], Knowledge [range 0-70]). Higher indicates more positive attitude towards people with dementia.
Measured: Baseline, 3-month post-intervention (month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start18 Apr 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Daphne Cheung, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575026
- Sponsor's protocol ID
- 5-ZH2P
- Status last verified
- Sep 2023
- First submitted
- 11 Apr 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
PubMed 3337862Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Use of the Cornell scale in nondemented patients. J Am Geriatr Soc. 1988 Mar;36(3):230-6. doi: 10.1111/j.1532-5415.1988.tb01806.x.
PubMed 3339232Berntson, G. G., & Cacioppo, J. T. (2004). Heart rate variability: Stress and psychiatric conditions. In M. Malik & A. J. Camm (Eds.), Dynamic electrocardiography (pp. 57-64). Oxford, UK: Blackwell Publishing.
Cahill S, Pierce M, Werner P, Darley A, Bobersky A. A systematic review of the public's knowledge and understanding of Alzheimer's disease and dementia. Alzheimer Dis Assoc Disord. 2015 Jul-Sep;29(3):255-75. doi: 10.1097/WAD.0000000000000102.
PubMed 26207322Carpenter BD, Balsis S, Otilingam PG, Hanson PK, Gatz M. The Alzheimer's Disease Knowledge Scale: development and psychometric properties. Gerontologist. 2009 Apr;49(2):236-47. doi: 10.1093/geront/gnp023. Epub 2009 Mar 25.
PubMed 19363018Cheung DSK, Lai CKY, Wong FKY, Leung MCP. The effects of the music-with-movement intervention on the cognitive functions of people with moderate dementia: a randomized controlled trial. Aging Ment Health. 2018 Mar;22(3):306-315. doi: 10.1080/13607863.2016.1251571. Epub 2016 Nov 7.
PubMed 27819483Clary EG, Snyder M, Ridge RD, Copeland J, Stukas AA, Haugen J, Miene P. Understanding and assessing the motivations of volunteers: a functional approach. J Pers Soc Psychol. 1998 Jun;74(6):1516-30. doi: 10.1037//0022-3514.74.6.1516.
PubMed 9654757Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Darragh M, Booth RJ, Koschwanez HE, Sollers J 3rd, Broadbent E. Expectation and the placebo effect in inflammatory skin reactions: a randomised-controlled trial. J Psychosom Res. 2013 May;74(5):439-43. doi: 10.1016/j.jpsychores.2012.12.010. Epub 2013 Jan 24.
PubMed 23597333Galindo-Kuhn, R., & Guzley, R. M. (2002). The volunteer satisfaction index: Construct definition, measurement, development, and validation. Journal of social service research, 28(1), 45-68.
Harmer BJ, Orrell M. What is meaningful activity for people with dementia living in care homes? A comparison of the views of older people with dementia, staff and family carers. Aging Ment Health. 2008 Sep;12(5):548-58. doi: 10.1080/13607860802343019.
PubMed 18855170Liu H, Wang Y, Wang L. A review of non-contact, low-cost physiological information measurement based on photoplethysmographic imaging. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:2088-91. doi: 10.1109/EMBC.2012.6346371.
PubMed 23366332Krueger, R., & Casey, M. (2015). Participants in a focus group. In R. A. Krueger & M. A. Casey (Eds.), Focus Groups: A Practical Guide for Applied Research (5th ed., pp. 77-136). Thousand Oaks, California, USA: SAGE.
Kwok, T., Lam, K.-C., Yip, A., & Ho, F. (2011). Knowledge of dementia among undergraduates in the health and social care professions in Hong Kong. Social Work in Mental Health, 9(4), 287-301.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership With the Community to Improve the Well-being of People With Mild Cognitive Impairment (MCI)/Early Dementia and Their Caregivers With Music Intervention: an Effectiveness-Implementation Cluster Randomized Clinical Hybrid Trial
- ClinicalTrials.gov ID
- NCT03575026
- Acronym / sponsor ID
- 5-ZH2P
- Conditions
- Dementia
- Keywords
- Early dementia, Caregiver, Anxiety, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 2 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.
This is a 12-week cluster randomized controlled trial utilizing music-with-movement (MWM) intervention compared with usual care to investigate the effect of MWM among subjects with early dementia or mild cognitive impairment implemented by their caregivers at home.
Detailed description
Dementia is a neurodegenerative disorder and it can adversely affect patient's cognitive, behavioural, social and emotional functioning. Its prevalence will increase continuously because of the increase in aging population and it is predicted that around 333,000 people in Hong Kong (equivalent to 11% population aged 60 or above) will suffer from dementia in year 2039. The gradual functional decline, communication difficulties, the behavioural symptoms associated with cognitive impairment, may affect the relationships with the family members and the wellbeing. A latest Cochrane Review commented that music-based intervention may be helpful to improve emotional wellbeing and quality of life according to some limited evidences, as well as depressive symptoms, although future studies with larger sample sizes and more rigorous research design are suggested
In 2014 - 2016, our team has modified a music-with-movement intervention designed for nursing home residents with moderate dementia, into a protocol specified for caregiver-delivered home-based intervention to promote the psychosocial wellbeing of people with early dementia in Hong Kong. We found that the dyadic music-with-movement intervention yielded significant reduction on anxiety levels of people with early dementia as compared to control group. Similar, Särkämö and colleagues also found that caregiver-implemented music intervention group have reduced depression of people with early dementia and reduced caregiver burden. With the strong evidence that music intervention is useful in improving the wellbeing of people with early dementia and their family caregiver, it is essential to disseminate the culture-appropriated and validated intervention for promoting health and evaluate its effectiveness in real-practice setting by implementation research.
This research is anchored by a conceptual framework of leisure and subjective wellbeing. This framework explained that through participating in activities outside the obligated works (either paid or unpaid) that is subjectively regarded as leisure, would lead to an improvement of well-being through five psychological mechanisms, namely detachment-relaxation, autonomy, mastery, meaning and affiliation. Caregivers and care-recipients are found relaxed after participating in music intervention because they are temporary detached from the everyday caregiving chaos. Participating in an intervention designed by the participants themselves would increase their sense of autonomy and mastery. During the dyadic music intervention, the caregivers and people with MCI/early dementia would design their activities within the music-with-movement framework after instruction of music therapist that allow them to exercise their choices based on their music preference. Through the interaction in the dyadic intervention, it has been found that through participating in dyadic music intervention, people with dementia and their caregivers have improved in relationship and social inclusiveness. Caregivers would feel their competence or mastery in the skills when leading music intervention. Staff and caregivers reported that activities that address the psychological needs, provide enjoyment, value individuality, reinforce a sense of identity and belonging are meaningful to people with dementia. Therefore, we hypothesized that dyadic music-with-movement intervention would improve the subjective wellbeing of both the people with MCI/early dementia and their caregiver, if there are relevant implementation strategies to increase the ease of uptake of the intervention. For example, stress of caregivers could be relieved by successful music intervention.
When the aim is to maximize the uptake of the intervention in the real-life settings as a routine, we have to examine the influence of contextual factors on implementation. Hence, this study have three main objectives:
- To test the effectiveness of the dyadic music-with-movement intervention on wellbeing of people with MCI/early dementia, and of their caregivers in real-life settings;
- To conduct a process evaluation of the effectiveness-implementation study by gathering information on the implementation process; and
- To validate and extend the applicability of "Leisure \& Wellbeing" conceptual framework to the dyads. In this project, one of the implementation strategies to maximize the uptake of the music intervention by the dyads, is to train a team volunteers to support the caregivers and people with MCI/early dementia, which is a unique group of population. There is a general lack of knowledge and inappropriate attitude towards dementia or Alzheimer's disease worldwide. In Hong Kong, it was reported that university students majoring in medicine, nursing, occupational therapy and social work showed inadequate knowledge towards this group of patients. By providing training for volunteers to support participating dyads, it would be able to provide a better understanding on dementia and create a supportive community for dementia. Therefore, we will explore the changes in the following outcomes of the volunteers:
- To examine the change of knowledge and attitudes towards dementia of the volunteers before and after participating in the project; and
- To examine the change of satisfaction and motivation to volunteering before and after participating in the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Music-with-movementSubjects will receive 12-week music-with-movement intervention at home by their trained caregivers for 12 weeks, at least 3 sessions per week and 30 minutes for each session. |
| Wait-list control | Placebo comparator | Behavioral: Usual careSubjects will receive 12-week usual care (social activity) at home. Dose is similar to intervention arm. After the completion of 12-week usual care, subjects will receive the same music intervention as intervention arm. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 60 or above
- Cognitively impaired, defined by Global Deterioration Scale 3 or 4
- Community-dwelling
- With stable medical condition
- Able to communicate in Cantonese
Key exclusion criteria (8 listed)
- Suffering from any critical medical or psychiatric illnesses
- Unable to hear even using hearing aids
- Unable to sit independently for around 30 minutes
- Received music intervention within 6 months
- Participate in any clinical trial within 6 months prior to the start of study
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 |
|---|---|---|
| Music-with-movementSubjects will listen their preferred music and move their body actively with music | Behavioural | Intervention |
| Usual careSocial activity acts as control with similar dose and intensity with intervention arm | Behavioural | Wait-list control |
Primary outcome
Changes in patients' anxiety
Time frame: Baseline, immediate post-intervention (month 3)
Rating Anxiety in Dementia (RAID), total score (range 0-54), higher indicates higher anxiety level (score>=11 indicates clinically significant anxiety)
Changes in patients' depression
Time frame: Baseline, immediate post-intervention (month 3)
Cornell scale for depression in dementia (CSDD), total score (range 0-36), higher indicates higher depression
Changes in caregivers' stress and well-being
Time frame: Baseline, immediate post-intervention (month 3)
Perceived Stress Scale 10 (PSS-10), total score (range 0-40), higher indicates higher perceived stress
Changes in caregivers' stress
Time frame: Baseline, immediate post-intervention (month 3)
Heart Rate Variability (HRV)
Changes in caregivers' well-being
Time frame: Baseline, immediate post-intervention (month 3)
Positive Aspects of Caregiving scale (PAC), total score (range 0-44), higher indicates more gain from caregiving experience
Changes in caregivers' relationship with PWD
Time frame: Baseline, immediate post-intervention (month 3)
Quality of the Caregiver-Care Recipient Relationship, 4 questions (range 0-4 each), higher score indicates better relationship between caregiver and care recipient
4 secondary outcomes
Changes in volunteers' satisfaction from volunteering
Time frame: Baseline, 3-month post-intervention (month 6)
Changes in volunteers' expectation from volunteering
Time frame: Baseline, 3-month post-intervention (month 6)
Changes in volunteers' knowledge towards dementia
Time frame: Baseline, 3-month post-intervention (month 6)
Changes in volunteers' attitude towards dementia
Time frame: Baseline, 3-month post-intervention (month 6)
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 28 Sep 2023.
- Background: PubMed 3337862Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
- Background: PubMed 3339232Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Use of the Cornell scale in nondemented patients. J Am Geriatr Soc. 1988 Mar;36(3):230-6. doi: 10.1111/j.1532-5415.1988.tb01806.x.
- BackgroundBerntson, G. G., & Cacioppo, J. T. (2004). Heart rate variability: Stress and psychiatric conditions. In M. Malik & A. J. Camm (Eds.), Dynamic electrocardiography (pp. 57-64). Oxford, UK: Blackwell Publishing.
- Background: PubMed 26207322Cahill S, Pierce M, Werner P, Darley A, Bobersky A. A systematic review of the public's knowledge and understanding of Alzheimer's disease and dementia. Alzheimer Dis Assoc Disord. 2015 Jul-Sep;29(3):255-75. doi: 10.1097/WAD.0000000000000102.
- Background: PubMed 19363018Carpenter BD, Balsis S, Otilingam PG, Hanson PK, Gatz M. The Alzheimer's Disease Knowledge Scale: development and psychometric properties. Gerontologist. 2009 Apr;49(2):236-47. doi: 10.1093/geront/gnp023. Epub 2009 Mar 25.
- Background: PubMed 27819483Cheung DSK, Lai CKY, Wong FKY, Leung MCP. The effects of the music-with-movement intervention on the cognitive functions of people with moderate dementia: a randomized controlled trial. Aging Ment Health. 2018 Mar;22(3):306-315. doi: 10.1080/13607863.2016.1251571. Epub 2016 Nov 7.
- Background: PubMed 9654757Clary EG, Snyder M, Ridge RD, Copeland J, Stukas AA, Haugen J, Miene P. Understanding and assessing the motivations of volunteers: a functional approach. J Pers Soc Psychol. 1998 Jun;74(6):1516-30. doi: 10.1037//0022-3514.74.6.1516.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Background: PubMed 23597333Darragh M, Booth RJ, Koschwanez HE, Sollers J 3rd, Broadbent E. Expectation and the placebo effect in inflammatory skin reactions: a randomised-controlled trial. J Psychosom Res. 2013 May;74(5):439-43. doi: 10.1016/j.jpsychores.2012.12.010. Epub 2013 Jan 24.
- BackgroundGalindo-Kuhn, R., & Guzley, R. M. (2002). The volunteer satisfaction index: Construct definition, measurement, development, and validation. Journal of social service research, 28(1), 45-68.
- Background: PubMed 18855170Harmer BJ, Orrell M. What is meaningful activity for people with dementia living in care homes? A comparison of the views of older people with dementia, staff and family carers. Aging Ment Health. 2008 Sep;12(5):548-58. doi: 10.1080/13607860802343019.
- 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 Music-with-movement 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 8 inclusion and 8 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 28 Sep 2023. 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. Some participants in this study may receive a placebo. 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?
Changes in patients' anxiety (time frame: Baseline, immediate post-intervention (month 3)). The study lists 6 primary outcomes in all. 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 NCT03575026, which also lists 47 linked publications.
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 28 Sep 2023.