Young Onset Dementia - the Difficult Diagnosis and the Stressful Life for the Whole Family

A Nordic Multicentre Observational Study of Persons With Young Onset Dementia and Their Families - Factors Influencing Quality of Life, Theirs Specific Needs and the Use of Healthcare Resources

People diagnosed with young onset dementia are today mostly assigned to the same healthcare services as people developing dementia at an older age. They and their families are however in a quite different life situation, which is likely to generate different challenges and specific needs for tailored healthcare services, of importance in maintaining their perceived quality of life.

The investigators of this study wish to assess the factors influencing these families' quality of life, their specific needs and their use of healthcare services by the use a combination of quantitative and qualitative methods. The main aim of this study is to provide better future healthcare services to these families, and to develop a programme for optimal collaboration between specialist healthcare services and the local dementia teams.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Frontotemporal Dementia

Detailed Description

Background: Most common dementia cases in Young Onset dementia (YOD) are Alzheimer's disease (AD) and frontotemporal dementia (FTD). There is little knowledge about the impact on the affected families, especially with regard to FTD. Although their life situation and specific needs differ from that of older people, they are referred to the same healthcare services.

Hypothesis:

1. QoL is poorer among persons with FTD and their families compared to AD at baseline.
2. There is less worsening of QoL after two years in persons with AD and their families compared to FTD.
3. People with YOD have different needs for health care services than older people with dementia.
4. YOD and their families have more unmet needs than older people with dementia.

Methods: Nordic multicenter observational cohort study of YOD-AD and YOD-FTD. 75 persons in each group, living at home with their families, recruited from five Norwegian and four Nordic memory clinics. The control group consists of 100 older people with dementia age ≥70 years. The investigators use a combination of quantitative and qualitative methods.

The follow-up period of the persons with YOD and their family members is two years. Assessments are made at baseline, 12 and 24 months, with telephone check-ups at 6 and 18 months. The main assessment questionnaires are Quality of life in Alzheimer's disease (QoL-AD), Camberwell Assessment of Need in the Elderly (CANE), and Resource Utilization in Dementia Lite (RUD Lite).

Study aims for the quantitative part of the study:

1. To evaluate the quality of life of persons with YOD and their family members.
2. To identify and explore the specific needs of YOD and their families.
3. To assess the use of health resources and calculate the costs associated with care for YOD, in comparison with older persons with dementia.
4. To compare the functional characteristics of YOD with older people with dementia in terms of cognitive decline, impairment of activities of daily living, changes in behavior, and quality of life.

Study aims and methods for the qualitative part of the study:

1. To investigate how people living alone with young-onset dementia cope with everyday life and decision-making. A longitudinal study with qualitative interviews at 6, 12, 24, 36 and 48 months after initial diagnosis
2. To investigate how it is to be a spouse/cohabitation to a person with young-onset of frontotemporal dementia. A retrospective and prospective study with qualitative interviews.
3. To investigate adult children's experiences with the support they received after their parent with young-onset dementia received a dementia diagnose. A retrospective and prospective study with qualitative interviews.
4. To investigate carers of people with young-onset dementia experiences with the support contact service. A longitudinell study study with qualitative interviews.

Results: Inclusion starts Feb 2014. The objective of this study is to ensure optimally tailored service provision and future healthcare planning according to the specific needs of families of YOD, and develop a care programme in collaboration between primary and specialist healthcare services.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Norway
  • Vestfold
    • Tønsberg, Vestfold, Norway, 3103
      • Norwegian Centre for Ageing and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 69 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

YOD participants are community residing persons recruited from memory clinics in Norway and Nordic countries (Iceland, Sweden and Denmark).

Description

Inclusion Criteria:

• Debut of dementia symptoms before the age of 65 years, but age at time of inclusion may be up to 70 years.
• FTD (Neary et al 1998 criteria)
• Primary progressive aphasia (Mesulam 2003 criteria)
• AD (DSM-IV)
• Community living, excl. dementia-specific living facilities manned 24/7
• Family member with regular contact at least x 1/week.

Exclusion Criteria:

• Lack of informed consent
• No close or appropriate family member
• Frontal lobe dysfunction due to non-progressive injury, i.e. cerebral infarction
• Frontal lobe dysfunction due to motor neuron disease (ALS)
• Other dementia specific condition with frontal lobe dysfunction (Huntington, HIV, Down syndrome, alcoholic dementia)
• Mental retardation
• Current substance abuse, incl. excessive alcohol consumption for the past 12 months

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
YOD-FTD; Young onset dementia - frontotemporal dementia, 38 persons with their respective family members.
YOD-AD; Young onset dementia - Alzheimer's disease, 50 persons with their respective family members.
LOD; Late onset dementia >= 70 years of age; Control group of 100 persons with dementia (mostly AD and AD/vascular) and their respective family members. Data already collected in a previous study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Assessments by Quality of Life - Alzheimer's dementia (QoL-AD) and Euroqol-5D (EQ-5D), index person and family member; also by proxy (QoL-AD).	Baseline
Change from baseline in quality of life at 12 months	Assessments by Quality of Life - Alzheimer's dementia (QoL-AD) and Euroqol-5D (EQ-5D), index person and family member; also by proxy (QoL-AD).	Baseline, 12 months
Change from baseline in quality of life at 24 months	Assessments by Quality of Life - Alzheimer's dementia (QoL-AD) and Euroqol-5D (EQ-5D), index person and family member; also by proxy (QoL-AD).	Baseline, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific needs	Assessments by Camberwell Assessment of Need in the Elderly (CANE); 24 items for index person and 2 items for family member needs.	Baseline
Use of healthcare resources	Assessments by Resource utilization in dementia Lite (RUD Lite).	Baseline
Cognition	Assessments standardized by the National Registry of Dementia: Mini Mental Status-Norwegian revision (MMSE-NR), Clock drawing Test, Trail making test part A and B, 10-word list memory recall and recognition test, The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) visuospatial figure copying, FAS, Boston Naming Test, Informant questionnaire-on Cognitive decline in Dementia (IQ-CODE).	Baseline
Neuropsychiatric symptoms	Assessments by Neuropsychiatric Inventory- Questionnaire (NPI-Q).	Baseline
Activities of Daily Living (ADL)	Assessments by Lawton & Brody I-ADL and Physical Self-maintenance Scale (PSMS).	Baseline
Relative's stress	Assessments by Relative's Stress Scale (RSS).	Baseline
Specific needs	Assessments by Camberwell Assessment of Need in the Elderly (CANE); 24 items for index person and 2 items for family member needs.	12 months
Specific needs	Assessments by Camberwell Assessment of Need in the Elderly (CANE); 24 items for index person and 2 items for family member needs.	24 months
Use of healthcare resources	Assessments by Resource utilization in dementia Lite (RUD Lite).	12 months
Use of healthcare resources	Assessments by Resource utilization in dementia Lite (RUD Lite).	24 months
Cognition	Assessments standardized by the National Registry of Dementia: Mini Mental Status-Norwegian revision (MMSE-NR), Clock drawing Test, Trail making test part A and B, 10-word list memory recall and recognition test, The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) visuospatial figure copying, FAS, Boston Naming Test, Informant questionnaire-on Cognitive decline in Dementia (IQ-CODE).	12 months
Cognition	Assessments standardized by the National Registry of Dementia: Mini Mental Status-Norwegian revision (MMSE-NR), Clock drawing Test, Trail making test part A and B, 10-word list memory recall and recognition test, The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) visuospatial figure copying, FAS, Boston Naming Test, Informant questionnaire-on Cognitive decline in Dementia (IQ-CODE).	24 months
Neuropsychiatric symptoms	Assessments by Neuropsychiatric Inventory- Questionnaire (NPI-Q).	12 months
Neuropsychiatric symptoms	Assessments by Neuropsychiatric Inventory- Questionnaire (NPI-Q).	24 months
Activities of Daily Living (ADL)	Assessments by Lawton & Brody I-ADL and Physical Self-maintenance Scale (PSMS).	12 months
Relative's stress	Assessments by Relative's Stress Scale (RSS).	12 months
Activities of Daily Living (ADL)	Assessments by Lawton & Brody I-ADL and Physical Self-maintenance Scale (PSMS).	24 months
Relative's stress	Assessments by Relative's Stress Scale (RSS).	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical dementia rating	Assessments by Clinical dementia rating scale (CDR) .	Baseline
Awareness	Assessments by REED scale.	Baseline
Depressive symptoms	Assessments by Cornell Scale for Depression in Dementia (CSDD) by proxy, and using Geriatric Depression Scale (GDS) and Montgomery-Asberg Depression Rating Scale (MADRS) in family member.	Baseline
Coping	Assessments by Locus, 17 item, for index person and family member.	Baseline
Intercurrent disease	Assessments by telephone follow-up interview with index person and family member.	6 months
Medication		Baseline
Hospital admission	Assessments by telephone follow-up interview with index person and family member.	6 months
Changes in living conditions	Assessments by telephone follow-up interview with index person and family member.	6 months
Major life events	Assessments by telephone follow-up interview with index person and family member.	6 months
Apo E4-genotype	Whole blood collected at baseline, analysis may be performed at a later stage (stored in research bio bank).	Baseline
Clinical dementia rating	Assessments by Clinical dementia rating scale (CDR) .	12 months
Clinical dementia rating	Assessments by Clinical dementia rating scale (CDR) .	24 months
Awareness	Assessments by REED scale.	12 months
Awareness	Assessments by REED scale.	24 months
Depressive symptoms	Assessments by Cornell Scale for Depression in Dementia (CSDD) by proxy, and using Geriatric Depression Scale (GDS) and Montgomery-Asberg Depression Rating Scale (MADRS) in family member.	12 months
Depressive symptoms	Assessments by Cornell Scale for Depression in Dementia (CSDD) by proxy, and using Geriatric Depression Scale (GDS) and Montgomery-Asberg Depression Rating Scale (MADRS) in family member.	24 months
Coping	Assessments by Locus, 17 item, for index person and family member.	12 months
Coping	Assessments by Locus, 17 item, for index person and family member.	24 months
Intercurrent disease	Assessments by telephone follow-up interview with index person and family member.	18 months
Medication		12 months
Medication		24 months
Medication		6 months
Medication		18 months
Hospital admission	Assessments by telephone follow-up interview with index person and family member.	18 months
Changes in living conditions	Assessments by telephone follow-up interview with index person and family member.	18 months
Major life events	Assessments by telephone follow-up interview with index person and family member.	18 months

Collaborators and Investigators

• Sponsor: Norwegian Centre for Ageing and Health
• Collaborators: Karolinska University Hospital; Zealand University Hospital; Oslo University Hospital; The Research Council of Norway; Sykehuset Innlandet HF; The Hospital of Vestfold; Sykehuset Telemark; Landspitali University Hospital; Copenhagen University Hospital, Denmark; Haraldsplass Deaconess Hospital
• Investigators: Study Director: Geir Selbæk, MD, PhD, Norwegian Centre for Ageing and Health; Study Chair: Hege Kersten, CPh, PhD, Norwegian Centre for Ageing and Health; Study Chair: Aud Johannessen, DrPH, Norwegian Centre for Ageing and Health

Publications and helpful links

General Publications

• Hvidsten L, Engedal K, Selbaek G, Wyller TB, Saltyte Benth J, Bruvik F, Kersten H. Quality of life of family carers of persons with young-onset compared to late-onset dementia. Aging Ment Health. 2020 Sep;24(9):1394-1401. doi: 10.1080/13607863.2019.1617245. Epub 2019 May 20.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (ESTIMATE): February 4, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Quality of life; Frontotemporal dementia; Healthcare services; Young onset dementia; Specific needs; Healthcare resources in dementia
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Tauopathies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Dementia; Alzheimer Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: 229002