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Completed

NCT Number: NCT02937883

Empowerment Intervention for Persons With Young Onset Dementia

The purpose of this study is to evaluate the effects of an empowerment intervention for community-dwelling persons with young onset dementia and their informal caregivers.

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Key information

Conditions

Dementia Behavior Brain Diseases Central Nervous System Diseases Empowerment Mental Disorders Nervous System Diseases Neurocognitive Disorders Social Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florence

The Hague, Netherlands

About this study

This study focuses on the evaluation of an empowerment intervention developed for persons with young onset dementia and their informal caregivers. The empowerment intervention focuses on current capacities, maintenance of autonomy, and increasing the opportunities to feel useful. This pragmatic cluster randomized controlled trial aims to investigate (1) the effectiveness of the intervention concerning participants' well-being, quality of life, and behavioral issues, (2) the effect of the intervention on the informal caregivers' sense of competence and perceived distress, and (3) the impact of the intervention on healthcare costs. Furthermore, the investigators aim to study the feasibility of the intervention to frame an implementation strategy.

Participants in the intervention group will receive the intervention for 5 months. Participants of the control group receive care as usual.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with dementia before the age of 65
  • Living at home (community-dwelling)

Exclusion criteria

  • Dementia is caused by Down's syndrome, Huntington's disease, HIV or alcohol-related dementia.
  • Limited contact between the person with dementia and the informal caregiver (<3 times a week)

Treatment and study plan

Empowerment intervention

Other

Empowerment intervention for persons with young onset dementia

Primary outcomes

  1. Changes in self-management abilities

    Time frame: 5 months

    (Self-Management Ability Scale (SMAS))

Secondary outcomes

  1. Changes in quality of life

    Time frame: 5 months

    (Quality of life - Alzheimer Disease scale (QOL-AD))

  2. Changes in neuropsychiatric symptoms Questionnaire

    Time frame: 5 months

    (Neuropsychiatric Inventory (NPI-Q))

  3. Changes in disability

    Time frame: 5 months

    (Interview for Deterioration in Daily living activities in Dementia (IDDD))

  4. Changes in apathy

    Time frame: 5 months

    (abbreviated Apathy Evaluation Scale (AES-10))

  5. Caregiver measures:Competence (

    Time frame: 5 months

    Short Sense of Competence Questionnaire (SSCQ))

  6. Caregiver measures: Emotional distress

    Time frame: 5 months

    (NPI-Q distress score)

Other outcomes

  1. Analysis of qualitative focus group interviews with participants, caregivers and health care professionals

    Time frame: 5 months

    Qualitative evaluation of the intervention

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Effects of an Empowerment Intervention for Community-dwelling Persons With Young Onset Dementia and Their Informal Caregivers

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 19, 2016
Registry last updated
Sep 4, 2018

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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