Exploring supported conversation with familial caregivers of persons with dementia

ISRCTN ISRCTN17622451
DOI https://doi.org/10.1186/ISRCTN17622451
Secondary identifying numbers 102756
Submission date
16/08/2018
Registration date
05/09/2018
Last edited
11/06/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Joshua Troche
Public

4000 Central Florida Blvd
Orlando
32816
United States of America

Phone +1 (0)4078234390
Email jtroche@ucf.edu

Study information

Study designSingle-center interventional pre-post study design
Primary study designInterventional
Secondary study designPre-post design
Study setting(s)Other
Study typeTreatment
Scientific titleExploring supported conversation with familial caregivers of persons with dementia
Study objectivesSupported 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(s)The Institutional Review Board at the University of Central Florida, 12/05/2016, ref: SBE-16-12158
Health condition(s) or problem(s) studiedDementia
InterventionA 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 typeBehavioural
Primary outcome measureMeasured 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 measuresMeasured 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 study start date11/01/2016
Completion date19/09/2016

Eligibility

Participant type(s)Mixed
Age groupAdult
SexBoth
Target number of participants8
Total final enrolment8
Key inclusion criteria1. Individuals with mild to moderate dementia and their familial caregivers
2. Self-reported difficulties in communication
Key exclusion criteria1. History of other neurological disease other than dementia
2. institutional dwelling
Date of first enrolment15/05/2018
Date of final enrolment22/05/2018

Locations

Countries of recruitment

  • United States of America

Study participating centre

University of Central Florida
4000 Central Florida Blvd
Orlando
32816
United States of America

Sponsor information

University of Central Florida
University/education

4000 Central Florida Blvd
Orlando
32816
United States of America

ROR logo "ROR" https://ror.org/036nfer12

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date15/12/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planData will be disseminated and published after the conclusion of the trial. Primary and Secondary outcomes will be published.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 18/01/2019 11/06/2019 Yes No

Editorial Notes

11/06/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.