Condition category
Mental and Behavioural Disorders
Date applied
16/08/2018
Date assigned
05/09/2018
Last edited
11/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

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

Sponsor information

Organisation

University of Central Florida

Sponsor details

4000 Central Florida Blvd
Orlando
32816
United States of America

Sponsor type

University/education

Website

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)

Publication citations

Additional files

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.