Dementia (Diagnosis)DemToolNCT07355829
DemTool - Supporting Life With Dementia
A study testing Life with dementia in the community - Support group for family caregivers, Life with dementia in the community - Group course and Life with dementia in a care home- Group course in people with Dementia (Diagnosis), run by Danish Dementia Research Centre at 1 site in Denmark.
Trial summary
This study will investigate the effects of a Danish psychosocial intervention, specifically the DemTool - supporting life with dementia, on quality of life and caregiver strain in family caregivers of people with dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia (Diagnosis)
- What is being tested?
- Life with dementia in the community - Support group for family caregivers, Life with dementia in the community - Group course and Life with dementia in a care home- Group course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2021to 24 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at enrollment.
- Providing care for a family member with dementia.
- Speaking and understanding Danish.
Who cannot join
- Unable to give informed consent for the trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Dementia Research Centre, Rigshospitalet, University of Copenhagen
Copenhagen, 2100
About this study
This study will investigate the effects of a Danish psychosocial intervention, specifically the DemTool - supporting life with dementia, on quality of life and caregiver strain in family caregivers of people with dementia.
Read the detailed description
'DemTool - supporting life with dementia' was developed in Denmark by the Danish Dementia Research Centre with a focus on improving the quality of life of people with dementia and their family caregivers. DemTool was developed to assist professional caregivers in Danish municipalities. It is intended for use by professionals responsible for counseling and educating patients and their family caregivers in primary care settings. This study will examine the impact of DemTool on the quality of life and caregiver strain among family caregivers of individuals with dementia using self-reported data from questionnaires. Family caregivers who participated in the intervention were invited to complete a questionnaire before their inclusion in the study, which served as a baseline measure. They then filled out a follow-up questionnaire approximately one month after receiving their last intervention. Meanwhile, the treatment-as-usual group also completed a questionnaire before study inclusion and received a follow-up questionnaire two months after the baseline measure.
- Conditions
- Dementia (Diagnosis)
- Being tested
- Life with dementia in the community - Support group for family caregivers, Life with dementia in the community - Group course, Life with dementia in a care home- Group course
- Keywords
- Family caregivers, dementia, Psychosocial intervention
- Medical subject headings
- Dementia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life with dementia in the community - Support group for family caregiversBehavioural
This intervention aimed to promote coping and reduce caregiver burden through professional and peer support. It was delivered over a varied number of sessions, as this depended on the number of recruited participants in the municipalities. To support these sessions, booklets and fact sheets for family caregivers could be incorporated. These materials would cover various topics, including the psychological challenges and reactions faced by family caregivers, guidance on effective communication with people with dementia, and a guide to practical and legal issues. Further, there would be fact sheets addressing specific symptoms, such as memory loss, communication difficulties, depression, apathy, behavioral changes, and reduced awareness of symptoms. The use of these booklets and fact sheets in the intervention would be determined by the municipalities, allowing for adaptation to fit local contexts. Dementia coordinators within the community setting would implement this intervention.
Life with dementia in the community - Group courseBehavioural
This intervention aimed to provide information on, e.g., dementia diseases, everyday life with dementia, being a family caregiver, and planning the future. It was delivered over six sessions. To support the sessions, booklets and fact sheets for family caregivers were incorporated. Materials covered various topics, including, e.g., the psychological challenges and reactions faced by family caregivers, and information on accessing support and services. Additionally, fact sheets addressed specific symptoms, such as memory loss, communication difficulties, apathy, and behavioral changes. To support municipalities in implementing this intervention, the Danish Dementia Research Centre provided PowerPoint presentations and a suggested order for the topics covered in each session. However, municipalities have the flexibility to adapt the use of the PowerPoints and the sequence of the sessions to suit their local contexts. This was done by dementia coordinators within the community setting.
Life with dementia in a care home- Group courseBehavioural
This intervention aimed to provide information on dementia diseases, moving into a care home, person centered care, and communication. It was delivered over five sessions. To support the sessions, booklets and fact sheets for family caregivers were incorporated. Materials covered various topics, including, e.g., psychological challenges and reactions faced by family caregivers, and guidance on effective communication with people with dementia. Additionally, fact sheets addressed specific symptoms, such as memory loss, communication difficulties, behavioral changes, and reduced awareness of symptoms. To support municipalities in implementing this, the Danish Dementia Research Centre provided PowerPoint presentations and a suggested order for the topics covered in each session. However, municipalities have the flexibility to adapt the use of PowerPoints and the sequence of sessions to suit their local contexts. This was carried out by dementia coordinators within the community setting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The trial included 15 municipalities in the intervention group. Family caregivers in the intervention group received one or two of the tailored interventions based on their level of burden and specific needs, as assessed by the local primary care dementia coordinator in the municipality. The interventions included: 1) a support group focused on addressing caregiver burden, providing both professional and peer support; 2) a group course consisting of six sessions aimed at helping caregivers cope with everyday challenges; and 3) a group course over five sessions that offered information on dementia, transitioning to a nursing home, person-centered care, and effective communication strategies. Receives: Behavioral: Life with dementia in the community - Support group for family caregivers; Behavioral: Life with dementia in the community - Group course; Behavioral: Life with dementia in a care home- Group course |
| Treatment-as-usual | No intervention | The trial included 15 municipalities in the treatment-as-usual group. Family caregivers in the treatment-as-usual group had access to local health and social services in their municipality, including support and information from primary care dementia coordinators, support groups, hotlines provided by patient associations, and respite care for the person with dementia in a home or daycare setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Neuropsychiatric Inventory - Distress (NPI-D)
Used to measure the emotional and psychological burden experienced by caregivers of patients with dementia.
Measured: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).
Change from baseline in European Quality of Life-Visual Analogue Scale (EQ VAS).
Used to measure a person's self-assessed general health on a given day. It's a vertical line scale from 0 (worst imaginable health) to 100 (best imaginable health), where respondents mark their current health state.
Measured: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).
Secondary outcomes (4)
Change from baseline in the 5-level EQ-5D version (EQ-5D-5L).
Used to measure quality of life in five dimensions, on a 5-point likert scale. Completing it generates a one-digit number for each dimension, which can be converted into a utility score. The closer the utility value is to 1, the better the health state. The EQ-5D-5L utility ranges from -0.757 to 1.
Measured: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).
Change from baseline in World Health Organization Wellbeing Index (WHO-5).
Assesses subjective psychological well-being over the past two weeks. Five questions are rated on a 6-point Likert scale. A higher score indicates better wellbeing.
Measured: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).
Change from baseline in University of California, Los Angeles Three-Item Loneliness Scale (UCLA 3-item).
Used to assess feelings of loneliness or social isolation via three questions on relational and social connectedness, and self-perceived isolation, rated on a 3-point Likert scale. Higher scores reflect greater loneliness.
Measured: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).
Change from baseline in Carer Experience Scale (CES).
A measure of caregiving experience in everyday life operationalized in six questions on a 3-point Likert scale. A total index score, calculated by adding preference weights, ranges from 0 to 100, where 0 indicates the poorest and 100 the best caregiving experience.
Measured: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 May 2021
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
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 Dementia (Diagnosis)Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Dementia Research Centre
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gunhild Waldemar, MD, D.M.Sc, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark.T. Rune Nielsen, PhD, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark.Ann Nielsen, MSPH, PhD, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355829
- Sponsor's protocol ID
- DemTool
- Acronym
- DemTool
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: While the study data are pseudonymized, participants did not consent to have their data shared with third parties beyond the study team. The informed consent form clearly restricted data usage to analyses conducted within the project and the publication of aggregated results in scientific articles. Sharing individual-level data would go beyond the original consent. Therefore, the dataset cannot be made publicly available.
Publications
Pedersen EK, Nielsen A, Nicolaisdottir DR, Oksnebjerg L, Tannebaek K, Janbek J, Waldemar G, Nielsen TR. Associations between a psychosocial intervention and quality of life and caregiver-related outcomes in family caregivers of people with dementia: the Danish DemTool trial. BMC Geriatr. 2026 Jun 27;26(1):975. doi: 10.1186/s12877-026-07835-7.
PubMed 42374285
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DemTool - Supporting Life With Dementia
- ClinicalTrials.gov ID
- NCT07355829
- Acronym / sponsor ID
- DemTool / DemTool
- Conditions
- Dementia (Diagnosis)
- Keywords
- Family caregivers, dementia, Psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Danish Dementia Research CentreResearch network
- Study start
- 1 May 2021 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 21 Jan 2026 (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.
This study will investigate the effects of a Danish psychosocial intervention, specifically the DemTool - supporting life with dementia, on quality of life and caregiver strain in family caregivers of people with dementia.
Detailed description
'DemTool - supporting life with dementia' was developed in Denmark by the Danish Dementia Research Centre with a focus on improving the quality of life of people with dementia and their family caregivers. DemTool was developed to assist professional caregivers in Danish municipalities. It is intended for use by professionals responsible for counseling and educating patients and their family caregivers in primary care settings. This study will examine the impact of DemTool on the quality of life and caregiver strain among family caregivers of individuals with dementia using self-reported data from questionnaires. Family caregivers who participated in the intervention were invited to complete a questionnaire before their inclusion in the study, which served as a baseline measure. They then filled out a follow-up questionnaire approximately one month after receiving their last intervention. Meanwhile, the treatment-as-usual group also completed a questionnaire before study inclusion and received a follow-up questionnaire two months after the baseline measure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Life with dementia in the community - Support group for family caregivers, Behavioral: Life with dementia in the community - Group course, Behavioral: Life with dementia in a care home- Group courseThe trial included 15 municipalities in the intervention group. Family caregivers in the intervention group received one or two of the tailored interventions based on their level of burden and specific needs, as assessed by the local primary care dementia coordinator in the municipality. The interventions included: 1) a support group focused on addressing caregiver burden, providing both professional and peer support; 2) a group course consisting of six sessions aimed at helping caregivers cope with everyday challenges; and 3) a group course over five sessions that offered information on dementia, transitioning to a nursing home, person-centered care, and effective communication strategies. |
| Treatment-as-usual | No intervention | –The trial included 15 municipalities in the treatment-as-usual group. Family caregivers in the treatment-as-usual group had access to local health and social services in their municipality, including support and information from primary care dementia coordinators, support groups, hotlines provided by patient associations, and respite care for the person with dementia in a home or daycare setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years at enrollment.
- Providing care for a family member with dementia.
- Speaking and understanding Danish.
Key exclusion criteria (1 listed)
- Unable to give informed consent for the trial
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 |
|---|---|---|
| Life with dementia in the community - Support group for family caregiversThis intervention aimed to promote coping and reduce caregiver burden through professional and peer support. It was delivered over a varied number of sessions, as this depended on the number of recruited participants in the municipalities. To support these sessions, booklets and fact sheets for family caregivers could be incorporated. These materials would cover various topics, including the psychological challenges and reactions faced by family caregivers, guidance on effective communication with people with dementia, and a guide to practical and legal issues. Further, there would be fact sheets addressing specific symptoms, such as memory loss, communication difficulties, depression, apathy, behavioral changes, and reduced awareness of symptoms. The use of these booklets and fact sheets in the intervention would be determined by the municipalities, allowing for adaptation to fit local contexts. Dementia coordinators within the community setting would implement this intervention. | Behavioural | Intervention |
| Life with dementia in the community - Group courseThis intervention aimed to provide information on, e.g., dementia diseases, everyday life with dementia, being a family caregiver, and planning the future. It was delivered over six sessions. To support the sessions, booklets and fact sheets for family caregivers were incorporated. Materials covered various topics, including, e.g., the psychological challenges and reactions faced by family caregivers, and information on accessing support and services. Additionally, fact sheets addressed specific symptoms, such as memory loss, communication difficulties, apathy, and behavioral changes. To support municipalities in implementing this intervention, the Danish Dementia Research Centre provided PowerPoint presentations and a suggested order for the topics covered in each session. However, municipalities have the flexibility to adapt the use of the PowerPoints and the sequence of the sessions to suit their local contexts. This was done by dementia coordinators within the community setting. | Behavioural | Intervention |
| Life with dementia in a care home- Group courseThis intervention aimed to provide information on dementia diseases, moving into a care home, person centered care, and communication. It was delivered over five sessions. To support the sessions, booklets and fact sheets for family caregivers were incorporated. Materials covered various topics, including, e.g., psychological challenges and reactions faced by family caregivers, and guidance on effective communication with people with dementia. Additionally, fact sheets addressed specific symptoms, such as memory loss, communication difficulties, behavioral changes, and reduced awareness of symptoms. To support municipalities in implementing this, the Danish Dementia Research Centre provided PowerPoint presentations and a suggested order for the topics covered in each session. However, municipalities have the flexibility to adapt the use of PowerPoints and the sequence of sessions to suit their local contexts. This was carried out by dementia coordinators within the community setting. | Behavioural | Intervention |
Primary outcome
Change from baseline in Neuropsychiatric Inventory - Distress (NPI-D)
Time frame: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).
Used to measure the emotional and psychological burden experienced by caregivers of patients with dementia.
Change from baseline in European Quality of Life-Visual Analogue Scale (EQ VAS).
Time frame: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).
Used to measure a person's self-assessed general health on a given day. It's a vertical line scale from 0 (worst imaginable health) to 100 (best imaginable health), where respondents mark their current health state.
4 secondary outcomes
Change from baseline in the 5-level EQ-5D version (EQ-5D-5L).
Time frame: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).
Change from baseline in World Health Organization Wellbeing Index (WHO-5).
Time frame: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).
Change from baseline in University of California, Los Angeles Three-Item Loneliness Scale (UCLA 3-item).
Time frame: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).
Change from baseline in Carer Experience Scale (CES).
Time frame: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 42374285Pedersen EK, Nielsen A, Nicolaisdottir DR, Oksnebjerg L, Tannebaek K, Janbek J, Waldemar G, Nielsen TR. Associations between a psychosocial intervention and quality of life and caregiver-related outcomes in family caregivers of people with dementia: the Danish DemTool trial. BMC Geriatr. 2026 Jun 27;26(1):975. doi: 10.1186/s12877-026-07835-7.
- Individual participant dataSharing planned: No. While the study data are pseudonymized, participants did not consent to have their data shared with third parties beyond the study team. The informed consent form clearly restricted data usage to analyses conducted within the project and the publication of aggregated results in scientific articles. Sharing individual-level data would go beyond the original consent. Therefore, the dataset cannot be made publicly available.
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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.
Gunhild Waldemar, MD, D.M.Sc principal investigator
Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark.
T. Rune Nielsen, PhD principal investigator
Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark.
Ann Nielsen, MSPH, PhD principal investigator
Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life with dementia in the community - Support group for family caregivers, Life with dementia in the community - Group course and Life with dementia in a care home- Group course in people with Dementia (Diagnosis), run by Danish Dementia Research Centre at 1 site in Denmark.
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: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Neuropsychiatric Inventory - Distress (NPI-D) (time frame: Outcome were measured at baseline (study inclusion) and follow-up (1 month after the last received intervention and 2 months from baseline in the treatment-as-usual group).). The study lists 2 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 NCT07355829, 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 21 Jan 2026.