Trajectories of Quality of Life by the Elderly in Early Phase of Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02845830
Recruitment Status : Not yet recruiting
First Posted : July 27, 2016
Last Update Posted : July 29, 2016
University Hospital Ostrava
University Hospital Hradec Kralove
Information provided by (Responsible Party):
Ing. Irena Jedličková, Palacky University

Brief Summary:
Maintaining of improving the quality of life amongst the elderly with early phase dementia (EwD) is nowadays one of the key aims of health care services. When investigating the quality of life trajectories, it is necessary to examine contributing factors. The aim of the project is to ascertain the profile of quality of life trajectory amongst Czech EwD and to identify the most important factors affecting it. The results will be compared to the results from the elderly without dementia. A quantitative approach, longitudinal prospected design utilising a battery of questionnaires in the Czech language will be used. At the same time, translation and validation of the Czech version of QOL-AD and PDI will be carried out. The group of respondents will include EwD and elderly without dementia living in home environment. Knowledge of the quality of life trajectory and the factors involved will enable interventions to maintain or improve the quality of life of the elderly with early-stage dementia in home environment in future. Project Aims The aims are to ascertain the quality of life trajectory profile amongst the elderly with early phase dementia, to identify the most important factors involved and to compare the results to control group. Validation of the Czech versions of QOL-AD and PDI questionnaires will be performed.

Condition or disease
Dementia Quality of Life

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 580 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Trajectories of Quality of Life by the Elderly in Early Phase of Dementia
Study Start Date : September 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Participants in early stage of dementia
Subjects with any type of dementia at an early phase diagnosed in the last 12 months with MMSE score 20-25 points
Participants without dementia
Subjects without dementia with MMSE score 26-30 points

Primary Outcome Measures :
  1. Quality of Life - Alzheimer's Disease (QOL-AD) [ Time Frame: 24 month ]
    Quality of life questionnaire

Secondary Outcome Measures :
  1. Geriatric Depression Scale by Yesavage (GDS-15) [ Time Frame: 24 month ]
    Depression questionnaire

  2. Mini Mental State Exam (MMSE) [ Time Frame: 24 month ]
    Cognitive function questionnaire

  3. Patient Dignity Inventory (PDI) [ Time Frame: 24 month ]
    Dignity questionnaire

  4. Attitude to Aging Questionnaire (AAQ) [ Time Frame: 24 month ]
    Attitude to aging questionnaire

Other Outcome Measures:
  1. Falls Efficacy Scale International (FES-I) [ Time Frame: 24 month ]
    Falls efficacy questionnaire

  2. Short Physical Performance Battery (SPPB) - Frail Index [ Time Frame: 24 month ]
    Physical performance questionnaire

  3. Bristol Activities of Daily Living Scale (BADLS-CZ) [ Time Frame: 24 month ]
    Activities of daily living questionnaire

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Elderly aged ≥60 years

Inclusion Criteria:

age ≥60 years lives at home MMSE 20 - 30 points contact with a family caregiver (if any) at least once a week who gives consent to be included in the survey

Exclusion Criteria:

severe psychic disorder severe sensory impairment (vision, hearing) long-term residence in a facility (care home)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02845830

Contact: Helena Kisvetrova, PhD 00420585632805
Contact: David Skoloudik, MD, PhD 00420585632802

Sponsors and Collaborators
Palacky University
University Hospital Ostrava
University Hospital Hradec Kralove
Principal Investigator: Helena Kisvetrova, PhD Faculty of Health Science, Palacký University Olomouc

Responsible Party: Ing. Irena Jedličková, Study coordinator, Palacky University Identifier: NCT02845830     History of Changes
Other Study ID Numbers: 16-28628A
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ing. Irena Jedličková, Palacky University:
quality of life
early stage

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders