Music Based Caregiving in Patients With Pain and Dementia

February 27, 2023 updated by: Tone Rustøen, Oslo University Hospital

In What Way do Music-based Caregiving Influence Pain, Daily Activity, QOL, Neuropsychiatric Symptoms, and Medication in Patients With Dementia

The main objective of this study is to evaluate the pain-relieving effect of a well-characterized non-pharmacological treatment program, music-based caregiving (MBC), to patients in nursing homes with dementia and pain. Patients with dementia disease will be recruited from nursing homes in Trondheim and Oslo, and each ward at the nursing homes will be cluster randomized into intervention - or control wards. Then the health care personnel in the intervention wards will receive education in MBC and perform the intervention during eight weeks. The hypothesis is that this non-pharmacological intervention will reduce pain intensity and improve general activity, as well as reduce other symptoms in nursing home patients with dementia and pain compared to baseline.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a cluster-randomized controlled trial including patients with dementia and pain living at different wards at eight nursing homes.

  1. About 12 nursing homes are selected to participate in Trondheim and in Oslo.
  2. All patients at the included nursing homes will be screened with respect to dementia and pain (see screening tools later). If patients have dementia and report pain (≥3 on MOBID 2) they will be included in the intervention part of the study (n=240).
  3. The included patients will then have a clinical examination of pain and pain management by expert physicians (see below). Evaluation of the use of analgesics and psychopharmacological medication will be performed. Inappropriate medication (both too much and too little) will be corrected in collaboration with the nursing home doctor.
  4. In addition to the clinical examination of pain, the investigators will measure total daily physical activity, ADL, QOL, and neuropsychiatric symptoms on all included patients.
  5. After the pre-test - a randomization of the wards into intervention wards or control wards will be performed.
  6. About five staff members at each of the wards randomized to the intervention group will receive education in the MBC before intervention.
  7. A post-test just after the intervention has ended, pain, total daily physical activity, ADL, QOL, and neuropsychiatric symptoms will be measured.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
276

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital
      • Trondheim, Norway
        • St. Olavs Hospital Trondheim University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients living in one of the included nursing homes in Oslo or Trondheim will be included in the first descriptive phase
  • Patients will be included in the intervention part if they report moderate pain or more (≥3 on MOBID) and mild dementia or more (≥1 on CDR).

Exclusion Criteria:

  • They will not be included if they have lived in the nursing home less than four weeks, have short (less than eight weeks) expected lifetime (judged by the nurses),or if they do not understand the Norwegian language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Receive the music based intervention
After the healthcare workers have accomplished the MBC program the eight week intervention program will be applied by the trained staff at the intervention wards. The intervention (MBC) consists of daily individualized prerecorded music integrated with activity with about 30 minutes duration, combined with a one hour active session in groups twice weekly. The music will be selected based on individualized preferences from the patients or their family. The music will also be adapted to the day rhythm; awakening in the morning, support activities during the day, or for sleep in the evening. The healthcare worker will bring playback equipment e.g. a CD-player to the patient room. In addition will two weekly sessions in groups be performed (each on one hour) with music and movement. The movement will be adapted to their physical capacity.
Behavioral: Music based caregiving
The intervention (MBC) consists of daily individualized prerecorded music integrated with activity with about 30 minutes duration, combined with a one hour active session in groups twice weekly. The music will be selected based on individualized preferences from the patients or their family. The music will also be adapted to the day rhythm; awakening in the morning, support activities during the day, or for sleep in the evening. The healthcare worker will bring playback equipment e.g. a CD-player to the patient room. In addition will two weekly sessions in groups be performed (each on one hour) with music and movement.
No Intervention: Standard care group
Standard care for participants in this group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Occurence
Time Frame: 8 weeks
MOBID 2 observation instrument. The assessment of inferred pain intensity is observed based on patient's pain behaviors during standardized, guided movements of different body parts (Part 1). In addition, MOBID-2 includes an observation of pain behavior related to internal organs, head and skin registered on pain drawings and monitored over time (Part 2). MOBID-2 has shown to be reliable, valid and time-effective to assess pain in patients with severe dementia. The investigators will use MOBID-2 for assessment of pain in all the patients with dementia. Scoring range is 0-10, the higher the score the more pain.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 8 weeks
Cornell scale for depression in dementia assesses signs and symptoms of major depression in patients with dementia in an interview with the health care providers. The scale consists of 19 items in five domains based on observation of behaviour. Each question is scored on a two-point scale: 0=absent; 1=mild or intermittent; 2=severe; n/a = unable to evaluate.
8 weeks
The Total Daily Physical Activity
Time Frame: 8 weeks
Two three-axis accelerometers attached to the skin on the right thigh and low back for seven continuous days. By utilizing state-of-the-art machine-learning techniques, the investigators have developed a preliminary activity recognition model for lying, sitting, standing, walking and other activities. This model has been used in the Nord-Trøndelag health study (HUNT4). Specifically, the model captures walking velocity and transitions between postures and activities (e.g. sit-to-stand) and sleep quality/duration.
8 weeks
Stage of Dementia Disease
Time Frame: 8 weeks
Clinical Dementia Rating Scale (CDR) is an assessment scale for the accurate clinical staging of dementia in older subjects. The CDR includes six items assessing cognitive and functional impairment. Based on an algorithm giving precedence to the item memory a total score is estimated. A score of 0, 0.5, 1, 2, 3 indicates no dementia, questionable dementia, mild, moderate or severe dementia, respectively, and CDR score > 1, is cut-off score for dementia disease. The scale has shown to be reliable and valid, also the Norwegian version.
8 weeks
Neuropsychiatric Symptoms
Time Frame: 8 weeks
The Neuropsychiatric Inventory (NPI-NH) measure 12 different psychiatric symptoms and behavioural disturbances in nursing home residents: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behaviour disorders, appetite and eating disorders. The screening question is asked to determine if the behavioural change is present. If a screening question is present, there will be sub-questions about frequency (score 1 to 4) and intensity (score 1 to 3) for each behavior. Total score for each behavior is from 1 to 12. The total scoring range is from 0-144, the higher the score the more symptoms. The scale has been validated for patients in nursing homes in Norway.
8 weeks
Level of Quality of Life: QUALID-scale
Time Frame: 8 weeks
Quality of Life in Late-Stage Dementia (QUALID) measures QOL in patients with severe dementia based on information and observations from nurses about the patient's emotions and behavior. Dementia Quality of Life (DQoL) will also be used as QUALID-scale is an observation scale, and there is a lack of studies comparing self-reported and observations QoL in those with dementia, the investigators want to compare the observation estimate with self-report for patients with none, mild and moderate dementia (DQoL). DQoL consists of five domains: self-esteem, positive affect/ humor, feeling of belonging, and sense of aesthetics and negative affect. The instrument is evaluated in those with mild and moderate dementia and is used in nursing homes in Norway. Scoring range is from 11-55, the higher the score the worse QOL.
8 weeks
Aids of Daily Living
Time Frame: 8 weeks
Barthel's Activities of Daily Living Index (ADL) is a screening instrument for patients' daily life functioning. This 10-point scale measures patients' degree of self-reliance with a total score ranging from 0 to 20. Lower scores indicate greater dependence on nursing care.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oslo
University of Bergen
Norwegian Centre for Ageing and Health
St. Olavs Hospital
Helse Midt-Norge

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tone Rustøen, PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/2519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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