Mild to Moderate DementiaNCT05561998
Talking Mats as Decision Aid for Older People Living With Mild to Moderate Dementia
A study testing TalkingMats and Usual conversation method in people with Mild to Moderate Dementia, run by Göteborg University at 3 sites in Sweden.
Trial summary
Sweden has an aging population and people with dementia often have their needs met in their own homes. The Social Services Act states that eldercare should aim at strengthening older people's ability to live an independent life, in dignity and with well-being. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild to Moderate Dementia
- What is being tested?
- TalkingMats and Usual conversation method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesSweden
- Study dates
- 15 Dec 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites, 3 recruiting
- Recruiting
Vård och äldreförvaltningen
Borås
Angela Bångsbo, PhD, angela.bangsbo@hb.se
- Not yet recruiting
Vård och äldreförvaltningen
Mark
Angela Bångsbo, PhD, angela.bangsbo@hb.se
- Not yet recruiting
Vård och äldreförvaltningen
Tranemo
Angela Bångsbo, PhD, angela.bangsbo@hb.se
About this study
Official title: 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
Sweden has an aging population and people with dementia often have their needs met in their own homes. The Social Services Act states that eldercare should aim at strengthening older people's ability to live an independent life, in dignity and with well-being. Although few would question the importance of influence and individualized support, research has shown that older people with extensive and complex needs, such as dementia, may be at risk of being excluded from the same opportunities as more privileged groups of eldercare recipients. Care managers and home care staff have to handle both the choice of services and providers as well as the more detailed design of the home care services without developed working methods that support the possibility of informed choices for people with dementia or other cognitive difficulties. The need for some form of decision aid in these situations has therefore been raised. So-called TalkingMats have in previous studies in the United Kingdom (UK) been shown to promote influence in decision-making for people with dementia. Within the framework of this study, our aim is therefore to evaluate the effect of TalkingMats as decision aid in needs assessment and planning home care services for people with mild to moderate dementia. The study is designed as a two-armed RCT study, where the effectiveness and implementation of TalkingMats are evaluated both quantitatively and qualitatively, in collaboration between eldercare in four municipalities in the Sjuhärad region, the Department of Social Work at Göteborg University, the University college of Borås and R \& D Sjuhärad Welfare.
Read the 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.
- Conditions
- Mild to Moderate Dementia
- Being tested
- TalkingMats, Usual conversation method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalkingMatsDevice
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.
Usual conversation methodOther
The standard procedure during needs-assessment conversation and conversations planning the provision of home care services.
| Study group | Role | What they receive |
|---|---|---|
| TalkingMats intervention group | Experimental | Participants will use TalkingMats as a decision aid for the needs-assessment conversation as well as in conversations planning the provision of social care. Receives: Device: TalkingMats |
| Usual conversation methods control group | Active comparator | Participants will use usual conversation methods in both the needs-assessment conversation and the provision planning conversations. Receives: Other: Usual conversation method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Involvement Measure Scale (IMS),
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.
Measured: Direct after the needs assessment conversations.
Involvement Measure Scale (IMS),
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.
Measured: Direct after the conversations about the performance of home care services.
Observing patient involvement in decision making (OPTION21)
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.
Measured: The duration of the conversations, about 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start15 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate DementiaStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The comparative intervention study is designed as a randomized controlled trial (RCT) where the use of TalkingMats 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.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 choice of care and services as well as choice of provider. The next situation is when home care staff carry out a conversation regarding the planning of the provision of the decided home care services. The participants will be randomized to one of two study arms, intervention group (n=50 and control group n=50).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Boras
- Responsible party
- Sponsor
- Investigators
- Anna Dunér, PhD, Principal investigator, University of Gorhenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561998
- Sponsor's protocol ID
- Forte 2021-01360
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duner A, Bangsbo A, Olsson TM. TalkingMats as a decision aid to promote involvement in choice and decision-making around home care services for older people with mild to moderate dementia - study protocol for a randomized controlled trial. BMC Geriatr. 2023 Apr 21;23(1):244. doi: 10.1186/s12877-023-03956-5.
PubMed 37085759
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05561998
- Acronym / sponsor ID
- Forte 2021-01360
- Conditions
- Mild to Moderate Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- University of Boras
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sweden has an aging population and people with dementia often have their needs met in their own homes. The Social Services Act states that eldercare should aim at strengthening older people's ability to live an independent life, in dignity and with well-being. Although few would question the importance of influence and individualized support, research has shown that older people with extensive and complex needs, such as dementia, may be at risk of being excluded from the same opportunities as more privileged groups of eldercare recipients. Care managers and home care staff have to handle both the choice of services and providers as well as the more detailed design of the home care services without developed working methods that support the possibility of informed choices for people with dementia or other cognitive difficulties. The need for some form of decision aid in these situations has therefore been raised. So-called TalkingMats have in previous studies in the United Kingdom (UK) been shown to promote influence in decision-making for people with dementia. Within the framework of this study, our aim is therefore to evaluate the effect of TalkingMats as decision aid in needs assessment and planning home care services for people with mild to moderate dementia. The study is designed as a two-armed RCT study, where the effectiveness and implementation of TalkingMats are evaluated both quantitatively and qualitatively, in collaboration between eldercare in four municipalities in the Sjuhärad region, the Department of Social Work at Göteborg University, the University college of Borås and R \& D Sjuhärad Welfare.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The comparative intervention study is designed as a randomized controlled trial (RCT) where the use of TalkingMats 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.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 choice of care and services as well as choice of provider. The next situation is when home care staff carry out a conversation regarding the planning of the provision of the decided home care services. The participants will be randomized to one of two study arms, intervention group (n=50 and control group n=50).
| Arm | Type | Receives |
|---|---|---|
| TalkingMats intervention group | Experimental | Device: TalkingMatsParticipants will use TalkingMats as a decision aid for the needs-assessment conversation as well as in conversations planning the provision of social care. |
| Usual conversation methods control group | Active comparator | Other: Usual conversation methodParticipants will use usual conversation methods in both the needs-assessment conversation and the provision planning conversations. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TalkingMatsTalkingMats 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. | Device | TalkingMats intervention group |
| Usual conversation methodThe standard procedure during needs-assessment conversation and conversations planning the provision of home care services. | Other | Usual conversation methods control group |
Primary outcome
Involvement Measure Scale (IMS),
Time frame: Direct after the needs assessment conversations.
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.
Involvement Measure Scale (IMS),
Time frame: Direct after the conversations about the performance of home care services.
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.
Observing patient involvement in decision making (OPTION21)
Time frame: The duration of the conversations, about 2 hours.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Derived from this study: PubMed 37085759Duner A, Bangsbo A, Olsson TM. TalkingMats as a decision aid to promote involvement in choice and decision-making around home care services for older people with mild to moderate dementia - study protocol for a randomized controlled trial. BMC Geriatr. 2023 Apr 21;23(1):244. doi: 10.1186/s12877-023-03956-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Dunér, PhD principal investigator
University of Gorhenburg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TalkingMats and Usual conversation method in people with Mild to Moderate Dementia, run by Göteborg University at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Professor (+46317865720, anna.duner@socwork.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Involvement Measure Scale (IMS), (time frame: Direct after the needs assessment conversations.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05561998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.