Clinical trial NCT04229446: Music Based Caregiving in Patients With Pain and Dementia
Official title: In What Way do Music-based Caregiving Influence Pain, Daily Activity, QOL, Neuropsychiatric Symptoms, and Medication in Patients With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Dementia
Music
Activity, Motor
Quality of Life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Midt-Norge
name: St. Olavs Hospital
name: University of Oslo
name: University of Bergen
name: Norwegian Centre for Ageing and Health
First posted: 2020-01-18
Enrollment: 276
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a cluster-randomized controlled trial including patients with dementia and pain living at different wards at nursing homes.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Occurence
timeFrame: 8 weeks
Secondary outcomes:
measure: The Total Daily Physical Activity
timeFrame: 8 weeks
measure: Stage of Dementia Disease
timeFrame: 8 weeks
measure: Neuropsychiatric Symptoms
timeFrame: 8 weeks
measure: Depression
timeFrame: 8 weeks
measure: Level of Quality of Life: QUALID-scale
timeFrame: 8 weeks
measure: Aids of Daily Living
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Trondheim
country: Norway
facility: St. Olavs hospital Trondheim University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Tone Rustøen, PhD
role: PRINCIPAL_INVESTIGATOR
References: