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
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
Public
4000 Central Florida Blvd
Orlando
32816
United States of America
| Phone | +1 (0)4078234390 |
|---|---|
| jtroche@ucf.edu |
Study information
| Study design | Single-center interventional pre-post study design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Pre-post design |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Exploring supported conversation with familial caregivers of persons with dementia |
| Study objectives | 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(s) | The Institutional Review Board at the University of Central Florida, 12/05/2016, ref: SBE-16-12158 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 11/01/2016 |
| Completion date | 19/09/2016 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 8 |
| Total final enrolment | 8 |
| Key inclusion criteria | 1. Individuals with mild to moderate dementia and their familial caregivers 2. Self-reported difficulties in communication |
| Key exclusion criteria | 1. History of other neurological disease other than dementia 2. institutional dwelling |
| Date of first enrolment | 15/05/2018 |
| Date of final enrolment | 22/05/2018 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Orlando
32816
United States of America
Sponsor information
University/education
4000 Central Florida Blvd
Orlando
32816
United States of America
"ROR" |
https://ror.org/036nfer12 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | 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. |
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.
