Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000711617
Ethics application status
Approved
Date submitted
12/06/2014
Date registered
4/07/2014
Date last updated
4/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
What are the effects of an electronic memory book on the quality and quantity of conversations in adults with mild to moderate dementia?
Scientific title
What are the effects of an electronic memory book, compared to no external memory aid, on the quality and quantity of conversations in adults with mild to moderate dementia?
Secondary ID [1] 284783 0
Nil known
Universal Trial Number (UTN)
U1111-1153-0368
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 292159 0
Condition category
Condition code
Neurological 292494 292494 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be involved in developing a memory book on an iPad using an app with the assistance of the researcher and their family member. This memory book will then be presented to the participant during treatment phases to measure the effect on the participant's on the quantity and quality of utterances. Each conversation will be transcribed verbatim by the researcher and analysed and coded as trained on-topic statements, novel on-topic statements, ambiguous utterances, unintelligible utterances, perseverative utterances, error statements, other utterances, partner prompts, partner statements, partner questions, and partner others. Participants will be engaged in a one-off session to develop the memory book which will take approximately 1 hour. Baseline and treatment sessions will commence over a 5 week period with 3 half-hour sessions a week. A maintenance phase will be conducted in week 7 of the study which will involve the participant in two sessions, one with the researcher, and one with their family member, to determine whether behaviours in treatment phase are maintained following a two week break and whether there is generalisation of observed behaviours with family member.
Intervention code [1] 289574 0
Behaviour
Intervention code [2] 289715 0
Treatment: Other
Comparator / control treatment
As this is a single-subject multiple baseline design, the control will be conversations without the memory book present during baseline phases.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292355 0
1. Factual on-topic statements made by participants
2. Sessions will be recorded using a digital video recorder and transcribed to be analysed for factual on-topic statements made by the participant during conversations in baseline, treatment and maintenance phases.
Timepoint [1] 292355 0
Primary outcome will be measured at baseline, treatment and maintenance phases.
The outcome will be assessed during a five minute conversation throughout each session at these time points (3 sessions per week for approximately 5 weeks, and again at week 7 for 2 sessions).
Primary outcome [2] 292356 0
1. Ambiguous utterances made by participants
2. Sessions will be recorded using a digital video recorder and transcribed to be analysed for ambiguous utterances made by the participant during conversations in baseline, treatment and maintenance phases.
Timepoint [2] 292356 0
Primary outcome will be measured at baseline, treatment and maintenance phases.
The outcome will be assessed during a five minute conversation throughout each session at these time points (3 sessions per week for approximately 5 weeks, and again at week 7 for 2 sessions).
Secondary outcome [1] 308754 0
1. Satisfaction level of the primary family member involved in the study
2. This will be assessed using a short 5-point likert scale questionnaire
Timepoint [1] 308754 0
Participant's family member will be recorded having a 5 minute conversation with the participant at baseline in week 1 and maintenance phase in week 7. Following this, the family member will be asked to complete a short questionnaire (7 questions) on a 5-point likert scale regarding their involvement with the study reflecting on their experiences and opinions of using a digital memory book to facilitate conversation.

Eligibility
Key inclusion criteria
Inclusion criteria for the participants with dementia for this study include: speak English; live at home with their spouse or another family member; have been diagnosed with dementia by a physician; able to hear adequately for one-on-one conversation as judged by the researcher; have passed the spaced-retrieval screen with the clinician; have a family member who is also willing to participate in the study; and able to use a swipe action to turn the page on an Apple iPad Trademark independently. Inclusion criteria for the family member participants in this study include: are 18 years of age or over); are a frequent conversational partner with the participant with dementia (on a daily basis) as indicated by self-report; speak English ; do not have a communication disorder (for example, aphasia) as indicated by self-report and are able to hear adequately for one-on-one conversation as judged by the researcher.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria for the participants in this study include: a comorbid psychiatric disorder or aphasia; severe visual impairment or blindness; hemiparesis which restricts ability to swipe across Apple iPad Trademark touch-screen.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be screened and those who meet inclusion criteria will be involved in the study until 4 participants have been enrolled. This is a single-subject multiple-baseline design so each participant will act as their own control during baseline measures. Each participant will receive intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Multiple baseline
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Literature demonstrated that a minimum of 4 participants are recommended for single-subject designs. Scoring
Behaviours identified in the study by Bourgeois (1990) and later replicated by Chang & Bourgeois (2012) will be used to code transcriptions. These include: Trained on-topic statements, Novel on-topic statements, Ambiguous utterances, Unintelligible utterances, Perseverative utterances, Error statements, Other utterances, Partner prompts, Partner statements, Partner questions, and Partner others. Number of utterances made by the participant will be calculated and compared to baseline.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment outside Australia
Country [1] 6134 0
New Zealand
State/province [1] 6134 0
Canterbury

Funding & Sponsors
Funding source category [1] 289399 0
Self funded/Unfunded
Name [1] 289399 0
Katrina Aitken
Country [1] 289399 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
20 Kirkwood Ave,
Upper Riccarton,
Christchurch 8041
Country
New Zealand
Secondary sponsor category [1] 288081 0
None
Name [1] 288081 0
Address [1] 288081 0
Country [1] 288081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291159 0
Health and Disability Ethics Committees
Ethics committee address [1] 291159 0
Ethics committee country [1] 291159 0
New Zealand
Date submitted for ethics approval [1] 291159 0
16/04/2014
Approval date [1] 291159 0
23/04/2014
Ethics approval number [1] 291159 0
14/STH/46
Ethics committee name [2] 291160 0
Human Ethic Committee, University of Canterbury
Ethics committee address [2] 291160 0
Ethics committee country [2] 291160 0
New Zealand
Date submitted for ethics approval [2] 291160 0
03/02/2014
Approval date [2] 291160 0
06/05/2014
Ethics approval number [2] 291160 0
HEC 2014/05

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 72 72 0 0
/AnzctrAttachments/366521-Aitken 2014 05[1].pdf
Attachments [2] 73 73 0 0
/AnzctrAttachments/366521-HDEC Letter 14STH46_Approved EXP Application.pdf
Attachments [3] 74 74 0 0
/AnzctrAttachments/366521-HEC_Application_Form -2014.docx

Contacts
Principal investigator
Name 49142 0
Miss Katrina Aitken
Address 49142 0
University of Canterbury
Department of Communication Disorders
Private Bag 4800
Christchurch, 8140
Country 49142 0
New Zealand
Phone 49142 0
+6427 6962692; +643 3377997 extn 66205
Fax 49142 0
Email 49142 0
[email protected]
Contact person for public queries
Name 49143 0
Katrina Aitken
Address 49143 0
University of Canterbury
Department of Communication Disorders
Private Bag 4800
Christchurch, 8140
Country 49143 0
New Zealand
Phone 49143 0
+6427 6962692; +643 3377997 extn 66205
Fax 49143 0
Email 49143 0
[email protected]
Contact person for scientific queries
Name 49144 0
Katrina Aitken
Address 49144 0
University of Canterbury
Department of Communication Disorders
Private Bag 4800
Christchurch, 8140
Country 49144 0
New Zealand
Phone 49144 0
+6427 6962692; +643 3377997 extn 66205
Fax 49144 0
Email 49144 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.