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Anxiety, Stress and Sleep Problems in People With Early Onset Dementia (Young-D)

Primary Purpose

Early Onset Dementia, Young Onset Dementia, Stress

Status
Not yet recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
young-D program
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Early Onset Dementia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diagnosed with early onset dementia before age of 65Y

Exclusion Criteria:

  • severe dementia

Sites / Locations

  • Odisee University of Applied Sciences
  • Familiezorg Oost Vlaanderen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group (pilot study)

Arm Description

needs detection by means of survey and interviews (mixed-methods) 6 week program (1 hour) on a weekly basis including cognitive behavioural therapy, sleep/stress hygiene education, heart coherence exercises, mindfulness and relaxation exercises

Outcomes

Primary Outcome Measures

anxiety (GAD7 validated questionnaire)
this is a subjective survey that measures the level of anxiety in daily life. It is a score of 7 items with a min of 0 and a max of 21. A higher score indicates a higher anxiety.
stress (perceived stress scale, PSS, validated questionnaire)
this is a subjective survey that measures the level of stress in daily life. It is a score of 10 items with a min of 0 and a max of 40. A higher score indicates a higher stress level.
sleep (Insomnia severity index, ISI, validated questionnaire)
this is a subjective survey that measures the level of insomnia. It is a score of 7 items with a min of 0 and a max of 28. A higher score indicates a worse level of insomnia
sleep (actigraph)
this is an objective measurement that measures the sleep quantity

Secondary Outcome Measures

emotional well being (WEMWBS, Warwick emotional mental wellbeing scale)
this is a subjective survey that measures the level of emotional well being in daily life. It is a score of14 items with a min of 0 and a max of 77. A higher score indicates a better wellbeing.
quality of life (QoL) (quality of life in dementia, QUALIDEM)
this is a subjective survey that measures the level of QoL in daily life. It is a score of 40 items with a min of 0 and a max of 160. Per (7) subscales the scores are cumulated.
heart rate variance (HRV)
this is an objective measurement that measures level of HRV in daily life, using (non-invasive photoplethysmography)
Depression (Patient Health Questionnaire PHQ-9, validated questionnaire)
this is a subjective survey that measures the level of depression in daily life. It is a score of 10 items with a min of 0 and a max of 27. A higher score indicates a more severe level of depression

Full Information

First Posted
June 2, 2022
Last Updated
September 23, 2022
Sponsor
KU Leuven
Collaborators
Odisee University college for applied sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05555381
Brief Title
Anxiety, Stress and Sleep Problems in People With Early Onset Dementia
Acronym
Young-D
Official Title
Anxiety, Stress and Sleep Problems in People With Early Onset Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Odisee University college for applied sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to detect and assess needs of people with early onset dementia regarding anxiety, stress and sleep implement a 6 week intervention pilot study in wich weekly (hourly) sessions are implemented in day care settings in order to decrease anxiety, stress and sleep problems in people with early onset dementia
Detailed Description
needs detection by means of survey and interviews implementation of a 6 week program in day care facilities

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Onset Dementia, Young Onset Dementia, Stress, Distress, Emotional, Anxiety, Sleep Problem, Sleep, Insomnia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (pilot study)
Arm Type
Experimental
Arm Description
needs detection by means of survey and interviews (mixed-methods) 6 week program (1 hour) on a weekly basis including cognitive behavioural therapy, sleep/stress hygiene education, heart coherence exercises, mindfulness and relaxation exercises
Intervention Type
Behavioral
Intervention Name(s)
young-D program
Intervention Description
needs detection by means of survey and interviews (mixed-methods) 6 week program (1 hour) on a weekly basis including cognitive behavioural therapy, sleep/stress hygiene education, heart coherence exercises, mindfulness and relaxation exercises
Primary Outcome Measure Information:
Title
anxiety (GAD7 validated questionnaire)
Description
this is a subjective survey that measures the level of anxiety in daily life. It is a score of 7 items with a min of 0 and a max of 21. A higher score indicates a higher anxiety.
Time Frame
6 weeks
Title
stress (perceived stress scale, PSS, validated questionnaire)
Description
this is a subjective survey that measures the level of stress in daily life. It is a score of 10 items with a min of 0 and a max of 40. A higher score indicates a higher stress level.
Time Frame
6 weeks
Title
sleep (Insomnia severity index, ISI, validated questionnaire)
Description
this is a subjective survey that measures the level of insomnia. It is a score of 7 items with a min of 0 and a max of 28. A higher score indicates a worse level of insomnia
Time Frame
6 weeks
Title
sleep (actigraph)
Description
this is an objective measurement that measures the sleep quantity
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
emotional well being (WEMWBS, Warwick emotional mental wellbeing scale)
Description
this is a subjective survey that measures the level of emotional well being in daily life. It is a score of14 items with a min of 0 and a max of 77. A higher score indicates a better wellbeing.
Time Frame
6 weeks
Title
quality of life (QoL) (quality of life in dementia, QUALIDEM)
Description
this is a subjective survey that measures the level of QoL in daily life. It is a score of 40 items with a min of 0 and a max of 160. Per (7) subscales the scores are cumulated.
Time Frame
6 weeks
Title
heart rate variance (HRV)
Description
this is an objective measurement that measures level of HRV in daily life, using (non-invasive photoplethysmography)
Time Frame
6 weeks
Title
Depression (Patient Health Questionnaire PHQ-9, validated questionnaire)
Description
this is a subjective survey that measures the level of depression in daily life. It is a score of 10 items with a min of 0 and a max of 27. A higher score indicates a more severe level of depression
Time Frame
6 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosed with early onset dementia before age of 65Y Exclusion Criteria: severe dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Vanderlinden, PhD
Organizational Affiliation
Odisee University of Applied Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odisee University of Applied Sciences
City
Brussel
State/Province
Flanders
ZIP/Postal Code
1000
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Vanderlinden, phd
Phone
+3253727170
Email
julie.vanderlinden@odisee.be
Facility Name
Familiezorg Oost Vlaanderen
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Vanderlinden
Phone
0478916956
Email
julie.vanderlinden@odisee.be

12. IPD Sharing Statement

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Anxiety, Stress and Sleep Problems in People With Early Onset Dementia

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