DementiaNCT02937883
Empowerment Intervention for Persons With Young Onset Dementia
A study testing Empowerment intervention in people with Dementia and Empowerment, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Empowerment
- What is being tested?
- Empowerment intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2016to Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with dementia before the age of 65
- Living at home (community-dwelling)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Empowerment Intervention for Community-dwelling Persons With Young Onset Dementia and Their Informal Caregivers
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.
Read the detailed description
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.
- Conditions
- Dementia, Empowerment
- Being tested
- Empowerment intervention
- Keywords
- Daily Activities
- Medical subject headings
- Dementia, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment interventionOther
Empowerment intervention for persons with young onset dementia
| Study group | Role | What they receive |
|---|---|---|
| empowerment intervention | Experimental | Empowerment intervention Receives: Other: Empowerment intervention |
| regular care | No intervention | Regular care, care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-management abilities
(Self-Management Ability Scale (SMAS))
Measured: 5 months
Secondary outcomes (6)
Changes in quality of life
(Quality of life - Alzheimer Disease scale (QOL-AD))
Measured: 5 months
Changes in neuropsychiatric symptoms Questionnaire
(Neuropsychiatric Inventory (NPI-Q))
Measured: 5 months
Changes in disability
(Interview for Deterioration in Daily living activities in Dementia (IDDD))
Measured: 5 months
Changes in apathy
(abbreviated Apathy Evaluation Scale (AES-10))
Measured: 5 months
Caregiver measures:Competence (
Short Sense of Competence Questionnaire (SSCQ))
Measured: 5 months
Caregiver measures: Emotional distress
(NPI-Q distress score)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2018
- Study completionJun 2018
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 DementiaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymond T CM Koopmans, MD, PhD, Principal investigator, Radboudumc Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937883
- Sponsor's protocol ID
- 733050607
- Status last verified
- Aug 2018
- First submitted
- 1 Aug 2016
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bielderman A, van Corven CTM, Koopmans RTCM, Leontjevas R, de Vugt ME, Bakker C, Gerritsen DL. Evaluation of the SPAN intervention for people living with young-onset dementia in the community and their family caregivers: a randomized controlled trial. Aging Ment Health. 2024 Jan-Feb;28(2):275-284. doi: 10.1080/13607863.2023.2260335. Epub 2024 Jan 31.
PubMed 37776001
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Empowerment Intervention for Community-dwelling Persons With Young Onset Dementia and Their Informal Caregivers
- ClinicalTrials.gov ID
- NCT02937883
- Acronym / sponsor ID
- 733050607
- Conditions
- Dementia, Empowerment
- Keywords
- Daily Activities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 19 Oct 2016 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| empowerment intervention | Experimental | Other: Empowerment interventionEmpowerment intervention |
| regular care | No intervention | –Regular care, care as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with dementia before the age of 65
- Living at home (community-dwelling)
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| Empowerment interventionEmpowerment intervention for persons with young onset dementia | Other | empowerment intervention |
Primary outcome
Changes in self-management abilities
Time frame: 5 months
(Self-Management Ability Scale (SMAS))
6 secondary outcomes
Changes in quality of life
Time frame: 5 months
Changes in neuropsychiatric symptoms Questionnaire
Time frame: 5 months
Changes in disability
Time frame: 5 months
Changes in apathy
Time frame: 5 months
Caregiver measures:Competence (
Time frame: 5 months
Caregiver measures: Emotional distress
Time frame: 5 months
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 4 Sep 2018.
- Derived from this study: PubMed 37776001Bielderman A, van Corven CTM, Koopmans RTCM, Leontjevas R, de Vugt ME, Bakker C, Gerritsen DL. Evaluation of the SPAN intervention for people living with young-onset dementia in the community and their family caregivers: a randomized controlled trial. Aging Ment Health. 2024 Jan-Feb;28(2):275-284. doi: 10.1080/13607863.2023.2260335. Epub 2024 Jan 31.
- Individual participant dataSharing planned: Undecided
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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.
Raymond T CM Koopmans, MD, PhD principal investigator
Radboudumc Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment intervention in people with Dementia and Empowerment, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 inclusion and 2 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 4 Sep 2018. 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 Netherlands. 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?
Changes in self-management abilities (time frame: 5 months). 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 NCT02937883, 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 4 Sep 2018.