NCT05561998

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

September 23, 2022

Last Update Submit

September 28, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    The duration of the conversations, about 2 hours.

Study Arms (2)

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.

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.

Other: Usual conversation method

Interventions

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.

TalkingMats intervention group

The standard procedure during needs-assessment conversation and conversations planning the provision of home care services.

Usual conversation methods control group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vård och äldreförvaltningen

Borås, Sweden

RECRUITING

Vård och äldreförvaltningen

Mark, Sweden

NOT YET RECRUITING

Vård och äldreförvaltningen

Tranemo, Sweden

NOT YET RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Anna Dunér, PhD

    University of Gorhenburg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 30, 2022

Study Start

December 15, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations