Clinical trial NCT03594851: Evaluation of the Benefits of Individualized Advice Administration on Quality of Sleep for the Elderly Living at Home
Official title: Evaluation of the Benefits of Individualized Advice Administration on Quality of Sleep for the Elderly Living at Home Prospective, Monocentric and Open Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Complaint, Subjective Health
Keywords: quality of sleep
elderly
health education
quantity of sleep
caregiver's burden
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Administration of individualized advice to older people living at home complaining of sleep disorders
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sleep disorder is often a complaint from the older people. Prevalence of sleep disorder increases with aging and reaches between 20 to 45% of the people of 65 years old and more. Sleep physiologically changes with aging. Sleep can also be disturbed by other factors such as intercurrent or related chronic pathologies, environmental change (institutionalized, death of a spouse...), or some medical treatments. Regardless of interindividual variabilities, normative criteria have been defined by a meta-analysis: insomnia can be diagnosed if night wakings are more than 60min and/or if sleep latency is more than 30 minutes.

Various studies have proved the major role of sleep on health and wellbeing. Sleep disorders have an impact on the quality of perception of health and on the quality of life of people and their spouse. According to the French High Health Authority recommendations, sleep diary and validated scales are the tools to use to investigate sleep disorders.

Results from previous studies brought us to consider sleep complaint more specifically and adjust to the heterogeneous population of the investigator's hospital with a subjective approach. This work intends to offer a program of individualized advice to older patients with no cognitive impairment, or with a mild or moderate cognitive impairment, who complain about their sleep quality. Patients with a moderate cognitive impairment who have a caregiver at home can also join the study. The main objective of the study is to evaluate the impact of individualized care for sleep disorders on quality of sleep using the Pittsburgh Sleep Quality Index which validity was demonstrated among the elderly.


Eligibility criteria: Inclusion Criteria:

1. Patient giving a signed informed consent
2. Patient complaining about their sleep
3. Patient living at home
4. Patient with a Mini Mental State Examination score of 10 or more If the Mini Mental State Examination score is between 10 and 20, caregiver living at home able and willing to be in charge of a sleep calendar
5. Patient able to fill in questionnaires

Exclusion Criteria:

1. Patient living in a senior living facility
2. Patient legally protected
3. Patient with a psychotic decompensation
4. Patient with a sleep pathology
5. Patient with a Lewy body disease at the time of enrollment
6. Patient with no health insurance

Primary outcomes:
measure: Evaluation of the benefits of individualized advice administration on sleep quality for the elderly living at home and complaining about their sleep
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Impact of a specific follow-up on quantity of sleep of elderly complaining about their sleep
timeFrame: Through study completion, an average of 6 months
measure: Impact of a specific follow up on quality of life of elderly complaining about their sleep
timeFrame: Through study completion, an average of 6 months
measure: Impact of a specific follow up on quality of life of elderly complaining about their sleep
timeFrame: Through study completion, an average of 6 months
measure: Impact of a specific follow up on quality of life of elderly complaining about their sleep
timeFrame: Through study completion, an average of 6 months
measure: Impact of a specific follow up on quality of life of elderly complaining about their sleep
timeFrame: Through study completion, an average of 6 months
measure: Impact of a specific follow up on quality of life of elderly complaining about their sleep
timeFrame: Through study completion, an average of 6 months
measure: Impact of a specific follow up on quality of life of elderly complaining about their sleep
timeFrame: Through study completion, an average of 6 months
measure: Impact of a specific follow up on quality of life of elderly complaining about their sleep
timeFrame: Through study completion, an average of 6 months
measure: Impact of a specific follow up on quality of life of elderly complaining about their sleep
timeFrame: Through study completion, an average of 6 months
measure: Impact of a specific follow up on quality of life of caregivers of elderly complaining about their sleep
timeFrame: Through study completion, an average of 6 months
measure: Impact of a specific follow up on the burden of caregivers of elderly complaining about their sleep
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: GHRMSA
Study officials:
affiliation: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
name: Anna Derajinski, MD
role: PRINCIPAL_INVESTIGATOR
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