Evaluating the Effects of Music Interventions on Hospitalised People With Dementia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by National Ageing Research Institute, Australia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Ageing Research Institute, Australia
ClinicalTrials.gov Identifier:
NCT00448318
First received: March 14, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Dementia
Alzheimer's Disease
Dementia, Vascular
Lewy Body Disease
Procedure: Music Therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Evaluating the Effects of Music Interventions on Hospitalised People With Dementia

Resource links provided by NLM:


Further study details as provided by National Ageing Research Institute, Australia:

Primary Outcome Measures:
  • Mini Mental State Examination: baseline cf. post intervention scores.
  • Hierarchic Dementia Scale: baseline cf. post intervention scores.
  • Geriatric Depression Scale: baseline cf. post intervention scores.
  • Note: post intervention measures taken within 24 hours of final therapeutic intervention session

Secondary Outcome Measures:
  • EEG fast/slow ratio: baseline cf. post intervention scores.
  • EEG Coherence: baseline cf. post intervention scores.
  • EEG evoked potentials:baseline cf. post intervention scores.
  • Note: post intervention measures taken within 24 hours of final therapeutic intervention session

Estimated Enrollment: 180
Study Start Date: March 2007
Estimated Study Completion Date: October 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of dementia

Exclusion Criteria:

  • delirium
  • acute medical conditions (eg pneumonia, cardiac failure)
  • primary psychiatric conditions (eg schizophrenia)
  • severe hearing impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448318

Contacts
Contact: Jonathan B Barber, PhD +61 3 8387 2638 b.barber@nari.unimelb.edu.au
Contact: John W Barlow, PhD +61 3 83872296 j.barlow@nari.unimelb.edu.au

Locations
Australia, Victoria
National Ageing Research Institute Not yet recruiting
Parkville, Victoria, Australia, 3052
Contact: John W Barlow, PhD    +61 3 8387 2296      
Principal Investigator: Jonathan B Barber, PhD         
Sponsors and Collaborators
National Ageing Research Institute, Australia
Investigators
Principal Investigator: Jonathan B Barber, PhD National Ageing Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00448318     History of Changes
Other Study ID Numbers: WKG_07_BB
Study First Received: March 14, 2007
Last Updated: March 14, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by National Ageing Research Institute, Australia:
Controlled clinical trial

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Delirium, Dementia, Amnestic, Cognitive Disorders
Alzheimer Disease
Lewy Body Disease
Arterial Occlusive Diseases
Arteriosclerosis
Basal Ganglia Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Leukoencephalopathies
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Tauopathies
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014