ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001799246

Ethics application status

Approved

Date submitted

29/10/2018

Date registered

5/11/2018

Date last updated

13/03/2023

Date data sharing statement initially provided

5/11/2018

Date results information initially provided

19/09/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Home-based family caregiver-delivered music Interventions for people living with dementia.

Scientific title

A HOME-based family caregiver-delivered music Intervention to manage behavioural and psychological symptoms of dementia: A Randomised Controlled Trial.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

HOMESIDE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

behavioural symptoms of dementia

depression

psychological symptoms of dementia

Lewy Body's Disease

Condition category

Condition code

Neurological

Dementias

Neurological

Alzheimer's disease

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Music Intervention (MI) will be provided to participant dyads allocated to the first intervention. Family caregivers (CGs) will receive a 2-hour home-based MI training session (delivered in-person or using video communication software) where a music therapist will instruct the CGs on methods and strategies for using music to assist the person living with dementia (PwD) to become calmer (if agitated) or more energised (if apathetic). CGs will be instructed on how to choose music and engage the PwD in effective and respectful discussions with the aim of evoking autobiographical memories and sharing meaningful experiences. Strategies to engage the PwD and create opportunities for meaningful dialogue with the PwD will be provided, as well as training CGs to notice the PwD’s positive and negative responses to music. The activities to be taught comprise: a) singing familiar/preferred music followed by CG-facilitated discussions about the meaning of the songs for the dyad, the PwD, and significant others, and any associated memories; b) movement to music (e.g. upper body and arms imitating familiar dance movements to music) to assist in regulating arousal; and c) listening to familiar/preferred relaxing or enlivening music dependent upon behavioural and psychological symptoms of dementia (BPSD) present at the time to assist in regulating arousal. Following training, the CG will try out some of the methods learned with the PwD while the music therapist is still present, and the music therapist will offer feedback and further guidance to enable the CG to experience the activities in action with immediate support from the music therapist. The session will take at least 60 minutes and up to 90 minutes and will continue until the CG feels confident to deliver the intervention unsupported. CGs are then instructed to deliver the MI at least 5x per week for approximately 30 mins over a 12-week period. At 3-weeks and 6-weeks post allocation, the MI trainer will return to the dyad’s home, or utilise video communication software as necessary, for a second and third training session to further extend CG knowledge and skills, and improve and monitor adherence to the protocol. These sessions will involve the MI trainer providing additional techniques for use within the MI program. These techniques will include how to combine gentle touch with singing, transitioning from dancing to relaxation, and further skill training in how to facilitate dialogue. Further, the trainer will observe the CG delivering the intervention with the PwD and the trainer will then provide additional feedback to help the CG hone his/her skills and increase the effectiveness of the intervention. Fortnightly phone conversations with CGs by those providing the MI training will be used to support the CG, check-in as to how they are progressing with the use of the MI and answer any questions they may have.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Reading Intervention (RI) will be provided to participant dyads allocated to the second intervention (comparator). Family caregivers will receive a 2-hour RI instruction session which aims to engage the PwD during and following the RI. The activities to be taught are based on RI methods commonly used with PwD including: a) CG reading aloud to PwD; b) PwD reading aloud to CG; and c) audio books. Strategies to engage the PwD and create opportunities for meaningful dialogue with the PwD will be provided as well as guidance on selecting reading material accessible to the PwD’s level of cognitive impairment. Like in the MI condition, this training will be delivered either in person or using video communication software as circumstances allow. CGs are then instructed to deliver RI at least 5x per week for 30 mins over 12-weeks. At 3-weeks and 6-weeks post allocation, the RI trainers will return to the dyad’s home, or utilise video communication software as necessary, for a second and third training session with the intention of further extending CG knowledge and skills and to improve and monitor intervention protocol adherence. These sessions will involve the RI trainer providing additional techniques for use within the RI program including suggesting additional types of reading material. Further, the trainer will observe the CG delivering the intervention with the PwD and the trainer will then provide additional feedback to help the CG hone his/her skills and increase the effectiveness of the intervention. Fortnightly phone conversations with CGs will be used to support the CG, check-in as to how they are progressing with the use of the RI, and answer any questions they may have about implementing the intervention.

Standard Care (control). Dyads randomly allocated to this condition will not be trained in either MI or RI but will be instructed to care for the PwD in their usual manner. For ethical reasons, those in the SC group will receive information about how to access local support when needed. Usual care means that CGs will receive no special instructions for how to manage the person they are caring for and so it is anticipated that CGs will continue to care for their family member in much the same way as they have been doing up until that point.

Control group

Active

Outcomes

Primary outcome [1]

behavioural and psychological symptoms of participants living with dementia as assessed by changes in Neuropsychiatric Inventory Questionnaire

Timepoint [1]

baseline, 12 weeks (primary time-point), and 6 months after intervention commencement

Secondary outcome [1]

changes in levels of depression in people living with dementia as assessed by Montgomery Asberg Depression Rating Scale

Timepoint [1]

baseline, 12 weeks and 6 months after intervention commencement

Secondary outcome [2]

changes in quality of life in the participant living with dementia as assessed by the Quality of Life-Alzheimer's Disease

Timepoint [2]