Plain English Summary
Background and study aims
Dementia can lead to difficulties in communication between caregivers and the individual with dementia. In this study, caregivers will be given a program to help them learn strategies to improve communication between them and the person under their care.
Who can participate?
Individuals with dementia and their familial caregivers who note communication difficulties
What does the study involve?
Caregivers are taught the program over a 4-week period and a week before and a week after the program the caregiver and the person under their care take part in assessments. The entire study takes 6 weeks.
What are the possible benefits and risks of participating?
Participants may get the benefit of improved communication. This study has no anticipated risks.
Where is the study run from?
University of Central Florida (USA)
When is the study starting and how long is it expected to run for?
January 2016 to September 2016
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Joshua Troche
jtroche@ucf.edu
Trial website
Contact information
Type
Public
Primary contact
Dr Joshua Troche
ORCID ID
Contact details
4000 Central Florida Blvd
Orlando
32816
United States of America
+1 (0)4078234390
jtroche@ucf.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
102756
Study information
Scientific title
Exploring supported conversation with familial caregivers of persons with dementia
Acronym
Study hypothesis
Supported Conversation for Adults with Aphasia can be adapted for individuals with dementia to help caregivers improve communication and participation between them and the person under their care.
Ethics approval
The Institutional Review Board at the University of Central Florida, 12/05/2016, ref: SBE-16-12158
Study design
Single-center interventional pre-post study design
Primary study design
Interventional
Secondary study design
Pre-post design
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Dementia
Intervention
A four-week course in an adapted Supported Conversations in Adults with Aphasia for individuals with dementia. Materials used in this study were taken and adapted from the learning modules provided in Supported Conversation for Adults with Aphasia (SCA). Information from the FOCUSED program and TANDEM model were used to modify portions of the SCA for caregivers of individuals with dementia. Training sessions are broken up into two components similarly to the original materials used in SCA: (1) acknowledging competence and (2) revealing competence. Revealing competence is further broken down into three sub-components: Getting the message in, getting the message out, and verifying the message. All information is presented as a slide presentation to caregivers as a group.
A week before and a week after the program the caregiver and the person under their care will take part in pre and post-assessment. The entire study will take 6 weeks.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Measured 1 week before the beginning of the 4-week course and 1 week after the 4-week course:
1. Ability to perform the strategies of Supported Conversation, measured using Measure of Skill in Supported Conversation (MSC)
2. Strength and participation in conversation, measured using Measure of Participation in Conversation (MPC)
3. Caregiver burden, measured using Zarit Burden Interview (ZBI)
Secondary outcome measures
Measured 1 week before the beginning of the 4-week course and 1 week after the 4-week course:
1. Unproductive behaviors in conversation, measured using trialists' own measure
2. Social validity (what caregivers thought of the program), measured using trialists' own measure
Overall trial start date
11/01/2016
Overall trial end date
19/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Individuals with mild to moderate dementia and their familial caregivers
2. Self-reported difficulties in communication
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
8
Total final enrolment
8
Participant exclusion criteria
1. History of other neurological disease other than dementia
2. institutional dwelling
Recruitment start date
15/05/2018
Recruitment end date
22/05/2018
Locations
Countries of recruitment
United States of America
Trial participating centre
University of Central Florida
4000 Central Florida Blvd
Orlando
32816
United States of America
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Data will be disseminated and published after the conclusion of the trial. Primary and Secondary outcomes will be published.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. All the raw data will be included in the publication of the manuscript.
Intention to publish date
15/12/2018
Participant level data
Other
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30680224 (added 11/06/2019)