DemTool - Supporting Life With Dementia

NCT07355829 | Completed

• 1 other identifier: DemTool
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia (Diagnosis)

Keywords

Family caregivers; dementia; Psychosocial intervention

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Neuropsychiatric Inventory - Distress (NPI-D)

  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).

  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 Outcomes (4)

• Change from baseline in the 5-level EQ-5D version (EQ-5D-5L).

  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).

  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).

  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).

  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).

Study Arms (2)

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.

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.

Interventions

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.

Intervention

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.

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to give informed consent for the trial

Sponsors & Collaborators

• Danish Dementia Research Centre: lead

Study Sites (1)

Danish Dementia Research Centre, Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Dementia; Disease

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 21, 2026
• Study Start: May 1, 2021
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)