Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448318
Status:
UNKNOWN
Last Update Posted:
2007-03-16
First Post:
2007-03-14
Brief Title:
Evaluating the Effects of Music Interventions on Hospitalised People With Dementia
Sponsor:
National Ageing Research Institute Australia
Organization:
National Ageing Research Institute Australia
Study Overview
Official Title:
Evaluating the Effects of Music Interventions on Hospitalised People With Dementia
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dementing syndromes are for the most part incurable People with dementia become highly dependent and frequently have to move from their homes into residential aged care facilities
Medications aimed at reducing the severity of a number of symptoms associated with the different types of dementia have had only modest success
Increasingly people with dementia their families and carers are turning to supplementary or alternative approaches to the management of their symptoms There are many published reports describing the successful use of music therapy in reducing the severity of many symptoms of dementia These include reports of improved memory improved language skills reduced anxiety and depression reductions in agitation and disruptive behaviours and better social relationships with family peers and carers However the quality of evidence they provide for the most part fails meet the standards of evidence required by health care providers This clinical trial will examine the effects of a music therapy intervention
The study will recruit 180 patients in sub-acute hospital wards Participants will be randomly placed in groups that receive either occupational therapy or music therapy Before the therapy programs begin we will use questionnaires to measure memory function language ability orientation and mood We will also record brain activity from the surface of the scalp blood pressure and pulse to examine physiological responses The same measures will be repeated after the 3 weeks of therapy to determine whether there has been any improvement in the symptoms of the participants and whether the group that had music therapy showed greater improvement than the group that had occupational therapy We will make a video recording during one therapy session to allow us to observe levels of engagement and to assess changes in facial expressions This will provide information about the immediate effects of music on mood and social interaction The information we collect about brain activity and blood pressure will help us to understand how music therapy might bring about changes in the symptoms of dementia This understanding will be useful in developing better applications of music therapy It will also add to our current knowledge about how the various diseases cause the problems they do
In summary the primary aim of the project is to determine whether the reported effects of music therapy are supported by objective evidence
Medications aimed at reducing the severity of a number of symptoms associated with the different types of dementia have had only modest success
Increasingly people with dementia their families and carers are turning to supplementary or alternative approaches to the management of their symptoms There are many published reports describing the successful use of music therapy in reducing the severity of many symptoms of dementia These include reports of improved memory improved language skills reduced anxiety and depression reductions in agitation and disruptive behaviours and better social relationships with family peers and carers However the quality of evidence they provide for the most part fails meet the standards of evidence required by health care providers This clinical trial will examine the effects of a music therapy intervention
The study will recruit 180 patients in sub-acute hospital wards Participants will be randomly placed in groups that receive either occupational therapy or music therapy Before the therapy programs begin we will use questionnaires to measure memory function language ability orientation and mood We will also record brain activity from the surface of the scalp blood pressure and pulse to examine physiological responses The same measures will be repeated after the 3 weeks of therapy to determine whether there has been any improvement in the symptoms of the participants and whether the group that had music therapy showed greater improvement than the group that had occupational therapy We will make a video recording during one therapy session to allow us to observe levels of engagement and to assess changes in facial expressions This will provide information about the immediate effects of music on mood and social interaction The information we collect about brain activity and blood pressure will help us to understand how music therapy might bring about changes in the symptoms of dementia This understanding will be useful in developing better applications of music therapy It will also add to our current knowledge about how the various diseases cause the problems they do
In summary the primary aim of the project is to determine whether the reported effects of music therapy are supported by objective evidence
Detailed Description:
RATIONALE Dementia presents a significant health problem throughout the world We will compare the effects of a music therapy intervention and an occupational therapy intervention in a randomised controlled trial conducted with hospitalised older people with dementia
The study will employ physiological psychometric and observer-rated measures to monitor change over time in a range of parameters including cognitive and behavioural responses mood and agitation CNS function facial expression and blood pressure The battery of psychometric instruments consists of well-validated and reliable measures Cognitive status will be measured using The Mini-Mental State Exam Folstein et al 1975 and the Hierarchic Dementia Scale Cole and Dastoor 1996 Mood will be assessed using the Geriatric Depression Scale Yesavage et al 1983 A wide range of behaviours will be assessed with the Cohen-Mansfield Agitation Inventory CMAI Cohen-Mansfield J 1986 To monitor changes related to the music and non-music interventions we will employ the EEG methods that will detect changes in dementia-related generalised global slowing of the EEG as well as more localised changes at sites in anterior and posterior regions of both cerebral hemispheres EEG-coherence methods will be used to assess intrahemispheric and interhemispheric functional interactions We will also record auditory evoked potentials to evaluate changes in the attentional status of participants This will provide data that will detect change over time in response to the interventions The Facial Activation Coding System Ekman Friesen 1978 allows systematic analysis of facial expressions from video-taped recordings It has been used with people with dementia to provide valid and reliable quantitative estimates of pain states Hadjistavropoulos et al 2000 It will be employed here to quantitatively evaluate changes in facial expression that occur during the intervention sessions This will allow us to observe within group changes and between group differences in the range of expressive responses Changes in blood pressure will provide a means of evaluating physiological responses to the interventions
AIMS The primary aim of the present study is to determine whether the symptomatic improvements attributed to music therapy are supported by empirical evidence derived from a battery of psychometric and observational measures A second aim is to determine whether neurophysiological measures EEG frequency EEG-coherence EP and vascular activity blood pressure reflect central nervous system and autonomic changes that directly correlate with reductions in dementia-related symptoms
Specifically the study will investigate the following hypotheses -
1 Music employed as a therapeutic medium will reduce symptomatic cognitive behavioural emotional and functional deficits associated with dementia
2 Symptomatic changes will correlate with physiological changes METHODOLOGY This study will take advantage of an established collaborative network between the Department of Psychiatry The University of Melbourne The National Ageing Research Institute The Cognitive Dementia and Memory Service CDAMS at The Royal Melbourne Hospital and the CDAMS at the St Georges Hospital campus of St Vincents Health The research team covers several disciplines including aged psychiatry neuropsychiatry geriatric medicine neuropsychology behavioural neuroscience electrophysiology music and music therapy
SUBJECTS One hundred and eighty sub-acute patients with mild moderate and severe dementia will be recruited from RMH Royal Park Campus and St Georges Hospital over a period of 18 months There will be a potential pool of approximately 800 patients over the planned 18 month data collection period We anticipate that with ineligibility of 30 an attrition rate of up to 20-25 and time lost to holidays and a participation rate of 70 our total cohort will be approximately 260 leaving substantial redundancy over the numbers required to power the study
Testing will commence when each patient has settled for one week when the majority of illnesses are stabilised and medications adjusted A full medical assessment will be available for all participants in order to evaluate medical comorbidity cognitive status and dementia diagnosis This information will include results of physical examination blood tests Ct scan informant history and neuropsychological assessment which includes the administration of the MMSE Folstein et al 1975 and classification according to DSM-IV ICD-10 and NINCDS-ARDRA criteria the current research gold standard for dementia diagnosis American Psychiatric Association 1994 Consensus diagnosis with information available will be made by the clinicians involved in the study Primary diagnoses comorbidities and medications will be monitored Recruitment will be undertaken in accordance with procedures approved by The Mental Health Research and Ethics Committee Melbourne Health Network the St Vincents Health Research Ethics Committee Given the nature of our participants diagnoses it is recognised that they cannot give informed consent
PROCEDURE Participants will be randomly assigned to either the music intervention group or the control occupational therapy group Both groups will undertake three 50 minute intervention sessions per week for three weeks giving a total of nine interventions Each session will be conducted with groups of 4 - 6 participants
Pre and post measures will be made on the day prior to the therapy session and the day after the last therapy session These measures are as follows
EEG recording made that will yield slowfast ratio data and resting state and music-listening EEG-coherence data and auditory evoked potential data
Four blood pressure and pulse readings taken at hourly intervals to establish a mean baseline
Questionnaires - Mini Mental State Examination Hierarchic Dementia Scale Geriatric Depression Scale will be administered prior to the first intervention session and after the ninth intervention session
Pre and post testing involving will take approximately 90 minutes in total Video recordings will be made using two cameras during the fifth therapy session The first camera will be located on a tripod such that the whole group including the therapist will be continuously in frame to facilitate subsequent observations about participation and social interactions The second camera will be hand held and will take film of the faces of each participant during the session for subsequent coding of changes in facial expressions using the Facial Activation Coding System
Further information will be compiled by members of the research team This information used to monitor comorbid conditions and pre and post changes will be derived from patient records It will be collected the following instruments
The Clinical Dementia rating Scale Hughes et al 1982
The Barthel Index Mahoney and Barthel 1965
The Cumulative Illness Rating Scale Linn et al 1968
The Neuropsychiatric Inventory Cummings 1997 Finally The Cohen-Mansfield Agitation Inventory Weiner et al 1998 will administered pre and post intervention by a researcher in consultation with nursing staff
In addition to the above measures the full range of treatments outside the music therapy interventions received by participants in both groups will be documented This will enable the researchers to monitor the levels of therapist contact experienced by participants in both the music therapy and control groups It will also provide data that may be used as covariates in a number of statistical analyses
INCLUSION CRITERIAPeople with a clinical diagnosis of dementia who are currently in sub-acute aged care hospital wards EXCLUSION CRITERIA delirium acute medical conditions eg pneumonia and cardiac failure where it is likely that participation is contra-indicated primary psychiatric conditions severe hearing impairment RANDOMISATION PROCEDURES A stratified randomization procedure will be used to ensure that both the experimental and control groups are at least broadly homogeneous with respect to cognitive status The procedure will be applied separately within each of the two hospital facilities with allocation made progressively as people enter the study After consent has been acquired and the pre-intervention measures taken participants will be coded stratified into two levels according to MMSE scores then allocated to treatment groups according to the computer generated random sequences The sequences will be generated using research randomiser an online web-based program httpwwwrandomizerorgformhtm The person responsible for implementing the allocation sequence will be either a member of the hospital staff or a NARI staff member who has no involvement in any other aspect of the study That person will be responsible for de-identifying participants using a conventional coding system Baseline and post-intervention data collection procedures will be administered by persons who have no other role in the project procedures and will remain blind to treatment allocation Baseline testing will take place before allocation As they will have no contact with participants during the intervention procedures and because patient identification is coded by an independent person the blind can be maintained As added protection psychometric instruments MMSE HDS and GDS will be assessed only once by an assessor for each participant That is if Assessor A administers the instruments with Participant A for baseline testing Assessor B will administer the instruments post-intervention for Participant A This will avoid any unintended prior knowledge of individual participant performance and so help to ensure post-treatment blinding with respect to active versus control group assignment The instruments to be used have clear and established implementation procedures with high inter-rater reliability After the post-intervention assessments have been taken for each participant the assessors will be asked to nominate which group they thought the participant was in A simple statistical analysis will be able to detect whether there is a significant bias in group assignment or whether assignment is no better than chance Bias may arise for example if one treatment group has an outcome that strongly differentiates it from the other It is noted that while there are other potential stratification factors eg age gender diagnoses the use of more factors rapidly becomes unfeasible Because current cognitive status has some prognostic relevance particularly with regard to music therapy it has been decided to use that measure as the sole stratification factor
STATISTICAL ANALYSES Given the multiple dependent variables being monitored in this study a MANOVA will be used to test for between-group differences with post-hoc univariate comparisons as required Based on previous studies at NARI referred to above using similar measures we expect that 90 subjects per group will detect a 25 change in mean values with at least 80 power alpha 05 For test-retest data a two way repeated measures MANOVA group time will be used to examine changes over the duration of the intervention group effects and the interaction between these factors Bivariate correlations and multiple regression analyses will be used to explore the relationships between the various measures EEG FACS MMSE HDS self-report and observational measures Similar comparisons can also be made for change scores within each domain of parameters objective psychometric self-report and the way they co-vary over time
The study will employ physiological psychometric and observer-rated measures to monitor change over time in a range of parameters including cognitive and behavioural responses mood and agitation CNS function facial expression and blood pressure The battery of psychometric instruments consists of well-validated and reliable measures Cognitive status will be measured using The Mini-Mental State Exam Folstein et al 1975 and the Hierarchic Dementia Scale Cole and Dastoor 1996 Mood will be assessed using the Geriatric Depression Scale Yesavage et al 1983 A wide range of behaviours will be assessed with the Cohen-Mansfield Agitation Inventory CMAI Cohen-Mansfield J 1986 To monitor changes related to the music and non-music interventions we will employ the EEG methods that will detect changes in dementia-related generalised global slowing of the EEG as well as more localised changes at sites in anterior and posterior regions of both cerebral hemispheres EEG-coherence methods will be used to assess intrahemispheric and interhemispheric functional interactions We will also record auditory evoked potentials to evaluate changes in the attentional status of participants This will provide data that will detect change over time in response to the interventions The Facial Activation Coding System Ekman Friesen 1978 allows systematic analysis of facial expressions from video-taped recordings It has been used with people with dementia to provide valid and reliable quantitative estimates of pain states Hadjistavropoulos et al 2000 It will be employed here to quantitatively evaluate changes in facial expression that occur during the intervention sessions This will allow us to observe within group changes and between group differences in the range of expressive responses Changes in blood pressure will provide a means of evaluating physiological responses to the interventions
AIMS The primary aim of the present study is to determine whether the symptomatic improvements attributed to music therapy are supported by empirical evidence derived from a battery of psychometric and observational measures A second aim is to determine whether neurophysiological measures EEG frequency EEG-coherence EP and vascular activity blood pressure reflect central nervous system and autonomic changes that directly correlate with reductions in dementia-related symptoms
Specifically the study will investigate the following hypotheses -
1 Music employed as a therapeutic medium will reduce symptomatic cognitive behavioural emotional and functional deficits associated with dementia
2 Symptomatic changes will correlate with physiological changes METHODOLOGY This study will take advantage of an established collaborative network between the Department of Psychiatry The University of Melbourne The National Ageing Research Institute The Cognitive Dementia and Memory Service CDAMS at The Royal Melbourne Hospital and the CDAMS at the St Georges Hospital campus of St Vincents Health The research team covers several disciplines including aged psychiatry neuropsychiatry geriatric medicine neuropsychology behavioural neuroscience electrophysiology music and music therapy
SUBJECTS One hundred and eighty sub-acute patients with mild moderate and severe dementia will be recruited from RMH Royal Park Campus and St Georges Hospital over a period of 18 months There will be a potential pool of approximately 800 patients over the planned 18 month data collection period We anticipate that with ineligibility of 30 an attrition rate of up to 20-25 and time lost to holidays and a participation rate of 70 our total cohort will be approximately 260 leaving substantial redundancy over the numbers required to power the study
Testing will commence when each patient has settled for one week when the majority of illnesses are stabilised and medications adjusted A full medical assessment will be available for all participants in order to evaluate medical comorbidity cognitive status and dementia diagnosis This information will include results of physical examination blood tests Ct scan informant history and neuropsychological assessment which includes the administration of the MMSE Folstein et al 1975 and classification according to DSM-IV ICD-10 and NINCDS-ARDRA criteria the current research gold standard for dementia diagnosis American Psychiatric Association 1994 Consensus diagnosis with information available will be made by the clinicians involved in the study Primary diagnoses comorbidities and medications will be monitored Recruitment will be undertaken in accordance with procedures approved by The Mental Health Research and Ethics Committee Melbourne Health Network the St Vincents Health Research Ethics Committee Given the nature of our participants diagnoses it is recognised that they cannot give informed consent
PROCEDURE Participants will be randomly assigned to either the music intervention group or the control occupational therapy group Both groups will undertake three 50 minute intervention sessions per week for three weeks giving a total of nine interventions Each session will be conducted with groups of 4 - 6 participants
Pre and post measures will be made on the day prior to the therapy session and the day after the last therapy session These measures are as follows
EEG recording made that will yield slowfast ratio data and resting state and music-listening EEG-coherence data and auditory evoked potential data
Four blood pressure and pulse readings taken at hourly intervals to establish a mean baseline
Questionnaires - Mini Mental State Examination Hierarchic Dementia Scale Geriatric Depression Scale will be administered prior to the first intervention session and after the ninth intervention session
Pre and post testing involving will take approximately 90 minutes in total Video recordings will be made using two cameras during the fifth therapy session The first camera will be located on a tripod such that the whole group including the therapist will be continuously in frame to facilitate subsequent observations about participation and social interactions The second camera will be hand held and will take film of the faces of each participant during the session for subsequent coding of changes in facial expressions using the Facial Activation Coding System
Further information will be compiled by members of the research team This information used to monitor comorbid conditions and pre and post changes will be derived from patient records It will be collected the following instruments
The Clinical Dementia rating Scale Hughes et al 1982
The Barthel Index Mahoney and Barthel 1965
The Cumulative Illness Rating Scale Linn et al 1968
The Neuropsychiatric Inventory Cummings 1997 Finally The Cohen-Mansfield Agitation Inventory Weiner et al 1998 will administered pre and post intervention by a researcher in consultation with nursing staff
In addition to the above measures the full range of treatments outside the music therapy interventions received by participants in both groups will be documented This will enable the researchers to monitor the levels of therapist contact experienced by participants in both the music therapy and control groups It will also provide data that may be used as covariates in a number of statistical analyses
INCLUSION CRITERIAPeople with a clinical diagnosis of dementia who are currently in sub-acute aged care hospital wards EXCLUSION CRITERIA delirium acute medical conditions eg pneumonia and cardiac failure where it is likely that participation is contra-indicated primary psychiatric conditions severe hearing impairment RANDOMISATION PROCEDURES A stratified randomization procedure will be used to ensure that both the experimental and control groups are at least broadly homogeneous with respect to cognitive status The procedure will be applied separately within each of the two hospital facilities with allocation made progressively as people enter the study After consent has been acquired and the pre-intervention measures taken participants will be coded stratified into two levels according to MMSE scores then allocated to treatment groups according to the computer generated random sequences The sequences will be generated using research randomiser an online web-based program httpwwwrandomizerorgformhtm The person responsible for implementing the allocation sequence will be either a member of the hospital staff or a NARI staff member who has no involvement in any other aspect of the study That person will be responsible for de-identifying participants using a conventional coding system Baseline and post-intervention data collection procedures will be administered by persons who have no other role in the project procedures and will remain blind to treatment allocation Baseline testing will take place before allocation As they will have no contact with participants during the intervention procedures and because patient identification is coded by an independent person the blind can be maintained As added protection psychometric instruments MMSE HDS and GDS will be assessed only once by an assessor for each participant That is if Assessor A administers the instruments with Participant A for baseline testing Assessor B will administer the instruments post-intervention for Participant A This will avoid any unintended prior knowledge of individual participant performance and so help to ensure post-treatment blinding with respect to active versus control group assignment The instruments to be used have clear and established implementation procedures with high inter-rater reliability After the post-intervention assessments have been taken for each participant the assessors will be asked to nominate which group they thought the participant was in A simple statistical analysis will be able to detect whether there is a significant bias in group assignment or whether assignment is no better than chance Bias may arise for example if one treatment group has an outcome that strongly differentiates it from the other It is noted that while there are other potential stratification factors eg age gender diagnoses the use of more factors rapidly becomes unfeasible Because current cognitive status has some prognostic relevance particularly with regard to music therapy it has been decided to use that measure as the sole stratification factor
STATISTICAL ANALYSES Given the multiple dependent variables being monitored in this study a MANOVA will be used to test for between-group differences with post-hoc univariate comparisons as required Based on previous studies at NARI referred to above using similar measures we expect that 90 subjects per group will detect a 25 change in mean values with at least 80 power alpha 05 For test-retest data a two way repeated measures MANOVA group time will be used to examine changes over the duration of the intervention group effects and the interaction between these factors Bivariate correlations and multiple regression analyses will be used to explore the relationships between the various measures EEG FACS MMSE HDS self-report and observational measures Similar comparisons can also be made for change scores within each domain of parameters objective psychometric self-report and the way they co-vary over time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None