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Completed

NCT Number: NCT07355829

DemTool - Supporting Life With Dementia

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.

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Key information

Conditions

Dementia (Diagnosis) Brain Diseases Central Nervous System Diseases Dementia Disease Mental Disorders Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Dementia Research Centre, Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

About this study

'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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Life with dementia in the community - Support group for family caregivers

Behavioral

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 course

Behavioral

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 course

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Danish Dementia Research Centre

Network

Registry information

Acronym: DemTool

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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