- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05561998
Talking Mats as Decision Aid for Older People Living With Mild to Moderate Dementia
Talking Mats as Decision Aid to Promote Involvement in Choice and Decision-making Around Home Care Services for Older People Living With Mild to Moderate Dementia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study has a descriptive, analytical and experimental design. It will adopt a pragmatic approach, balancing the criteria of a methodologically sound clinical trial vs the criteria of a clinically useful research study. Thus, participants and context reflect real-world service users and circumstances rather than a highly selected 'clean' sample. The comparative intervention study is designed as a randomized controlled trial (RCT) where the use of TalkingMats (TM) as a decision aid to support influence, choice and control in home care services for people living with mild to moderate dementia will be evaluated through comparison with usual conversation methods (UCM).Two different situations where older people living with dementia have to make decisions about home care services will be studied; first a needs-assessment conversation by care managers working in eldercare concerning the follow up of decisions about home care services as well as choice of provider. The next situation is when home care staff carry out a conversation regarding performance of the decided home care services. The participants will be randomized to one of two study arms. The implementation will be studied and analysed along with the intervention, through video recordings of the clinical encounters and survey to the staff performing the intervention. In addition, explorative qualitative interviews will be performed with staff and study participants in order to gain an understanding of the intervention and its significance as well as of the implementation.
Study population The target group for the study is older people living with mild to moderate dementia, using for home care services at the eldercare authorities in the participating municipalities. Eligibility criteria is age 65+, using home help services at the eldercare authority in Borås, Mark, Tranemo or Ulricehamn municipalities, and living with mild to moderate dementia, defined as scoring between 12-23 at a mini-mental state examination (MMSE).
Procedure The recruitment of participants to the study has started and will continue until the planned number of participants is reached. Older people assessed as meeting the eligibility criteria, contacting the local eldercare authority, will be approached by a care manager and asked if they are willing to participate in the study. If so, they will be given an accessible information sheet about the project. On expression of interest, permission will be sought to forward their contact details to a researcher, who will make initial contact to arrange a convenient time to visit. To make certain that full and informed consent is obtained, the researcher will follow the comprehensive consent procedure undertaken in a previous study ensuring that all documentation is adapted accordingly and explained thoroughly and sensitively. Thereafter, the project assistant will perform a MMSE to assess whether the person meet the eligibility criteria and, if so, collect background data. Randomization and allocation to one of the two study arms will take place immediately after the first visit. To check for comparison group equivalence, we will compare the pre-test dementia scores, functional ability and demographic variables of the two groups.
Participants in the first study arm, interventions group, will use TM as a decision aid for the needs-assessment conversation as well as in conversations planning the provision of social care. Participants in the second study arm, control group, will use UCM in both the needs-assessment conversation and the provision planning conversations.
According to preliminary power calculations, we plan to include 50 participants in each study arm. The calculation was made based on what is needed to detect a moderate difference (.25 effect size) with .8 power, p = .05.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Professor
- Phone Number: +46317865720
- Email: anna.duner@socwork.gu.se
Study Locations
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Borås, Sweden
- Recruiting
- Vård och äldreförvaltningen
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Contact:
- Angela Bångsbo, PhD
- Email: angela.bangsbo@hb.se
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Mark, Sweden
- Not yet recruiting
- Vård och äldreförvaltningen
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Contact:
- Angela Bångsbo, PhD
- Email: angela.bangsbo@hb.se
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Tranemo, Sweden
- Not yet recruiting
- Vård och äldreförvaltningen
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Contact:
- Angela Bångsbo, PhD
- Email: angela.bangsbo@hb.se
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 65+
- using home care services at the eldercare authority in Borås, Mark, Tranemo or Ulricehamn municipalities
- living with mild to moderate dementia, defined as scoring between 12-23 at a mini-mental state examination (MMSE)
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TalkingMats intervention group
Participants will use TalkingMats as a decision aid for the needs-assessment conversation as well as in conversations planning the provision of social care.
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TalkingMats is a low-technology communication framework, to help people with communication difficulties to express their views.
It uses a simple system of picture symbols, placed on a textured mat, that allow people to indicate their feelings about various options within a topic by placing the relevant image below a visual scale.
Three sets of symbols are used, one set for the topics of the conversation, one set for the options within each topic and one set consisting of the value scale under which the options are placed.
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Active Comparator: Usual conversation methods control group
Participants will use usual conversation methods in both the needs-assessment conversation and the provision planning conversations.
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The standard procedure during needs-assessment conversation and conversations planning the provision of home care services.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Involvement Measure Scale (IMS),
Time Frame: Direct after the needs assessment conversations.
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A measure specifically designed for people with dementia to indicate how they rate their involvement in a situation where they had to consider issues around care.
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Direct after the needs assessment conversations.
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Involvement Measure Scale (IMS),
Time Frame: Direct after the conversations about the performance of home care services.
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A measure specifically designed for people with dementia to indicate how they rate their involvement in a situation where they had to consider issues around care.Ratings on a 7-point Likert scale will be used, where 0 = not very well at all and 6 = very well indeed.
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Direct after the conversations about the performance of home care services.
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Observing patient involvement in decision making (OPTION21)
Time Frame: The duration of the conversations, about 2 hours.
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Scale comprising of twelve items to evaluate the extent of which we could observe the care managers' and home care staff's efforts to involve older people in the decision-making process during the conversations from an objective rater perspective.A magnitude based five-point scale will be applied, where 0 = the behavior is not observed and 4 = the behavior is observed and executed to a high standard.
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The duration of the conversations, about 2 hours.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anna Dunér, PhD, University of Gorhenburg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Forte 2021-01360
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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