DemTool - Supporting Life With Dementia (DemTool)

January 13, 2026 updated by: Danish Dementia Research Centre
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
272

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Danish Dementia Research Centre, Rigshospitalet, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years at enrollment.
  • Providing care for a family member with dementia.
  • Speaking and understanding Danish.

Exclusion Criteria:

  • Unable to give informed consent for the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
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.
Behavioral: Life with dementia in the community - Support group for family caregivers
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.
Behavioral: Life with dementia in the community - Group course
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.
Behavioral: Life with dementia in a care home- Group course
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.
No Intervention: Treatment-as-usual
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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).
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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.
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).
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.
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).
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.
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).
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Danish Dementia Research Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gunhild Waldemar, MD, D.M.Sc, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark.
  • Principal Investigator: T. Rune Nielsen, PhD, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark.
  • Principal Investigator: Ann Nielsen, MSPH, PhD, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DemTool

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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