Trial Outcomes & Findings for Music Based Caregiving in Patients With Pain and Dementia (NCT NCT04229446)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

276 participants

Primary outcome timeframe

8 weeks

Results posted on

2023-12-07

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.	Standard Care Group The participants allocated to this group received the best of standard care.
Overall Study STARTED	134	142
Overall Study COMPLETED	117	124
Overall Study NOT COMPLETED	17	18

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.	Standard Care Group The participants allocated to this group received the best of standard care.
Overall Study Death	12	10
Overall Study Lost to Follow-up	5	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Receive the Music Based Intervention n=134 Participants 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. 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.	Standard Care Group n=142 Participants The patients will receive thei best of stand care	Total n=276 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=134 Participants	0 Participants n=142 Participants	0 Participants n=276 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=134 Participants	1 Participants n=142 Participants	2 Participants n=276 Participants
Age, Categorical >=65 years	133 Participants n=134 Participants	141 Participants n=142 Participants	274 Participants n=276 Participants
Age, Continuous	87 years n=134 Participants	86 years n=142 Participants	86 years n=276 Participants
Sex: Female, Male Female	96 Participants n=134 Participants	100 Participants n=142 Participants	196 Participants n=276 Participants
Sex: Female, Male Male	38 Participants n=134 Participants	42 Participants n=142 Participants	80 Participants n=276 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Norway	134 participants n=134 Participants	142 participants n=142 Participants	276 participants n=276 Participants
MOBID-2 pain scale	5 units on a scale n=134 Participants	5 units on a scale n=142 Participants	5 units on a scale n=276 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Receive the Music Based Intervention n=134 Participants 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. 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.	Standard Care Group n=142 Participants Standard care will be provided
Pain Occurence	4.6 units on Mobid-2 pain scale ( 0-10) Interval 4.3 to 4.8	4.6 units on Mobid-2 pain scale ( 0-10) Interval 4.4 to 4.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Receive the Music Based Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 12 deaths

Standard Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Primary Investigator Dr. Tone Rustøen

OsloUH

Phone: +47 22859229

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place