Evaluation of the Benefits of Individualized Advice Administration on Quality of Sleep for the Elderly Living at Home

Not Applicable

Completed

• Conditions: Sleep Disorder; Complaint, Subjective Health
• Interventions: Behavioral: Pittsburgh Sleep Quality Index; Behavioral: Sleep diary; Behavioral: Katz Index of Independence in Activities of Daily Living; Behavioral: Lawton Instrumental Activities of Daily Living; Behavioral: Neuropsychiatric Inventory (Cummings); Behavioral: Mini Zarit Caregiver Burden Scale, for the caregiver; Behavioral: Mini Mental state examination; Behavioral: Cornell Scale for Depression in Dementia; Behavioral: Quality of Life in Alzheimer's Disease

• Registration Number: NCT03594851
• Lead Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Study First Submitted: 2018-05-22
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-20
• Primary Completion: 2019-07-08
• Study Completion: 2019-07-30
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of individualized advice	Lawton Instrumental Activities of Daily Living	Administration of individualized advice to improve the quality of older people's sleep, based on the following interventions : Pittsburgh Sleep Quality Index, Sleep diary, Mini Mental State Examination, Autonomy assessment (Katz Index of Independence in Activities of Daily Living \& Lawton Instrumental Activities of Daily Living), Neuropsychiatric Inventory (Cummings) for the caregiver, if applicable, Mini Zarit Caregiver Burden Scale, for the caregiver, if applicable, Cornell Scale for Depression in Dementia, Quality of Life in Alzheimer's Disease, Neuropsychiatric Inventory
Administration of individualized advice	Katz Index of Independence in Activities of Daily Living	Administration of individualized advice to improve the quality of older people's sleep, based on the following interventions : Pittsburgh Sleep Quality Index, Sleep diary, Mini Mental State Examination, Autonomy assessment (Katz Index of Independence in Activities of Daily Living \& Lawton Instrumental Activities of Daily Living), Neuropsychiatric Inventory (Cummings) for the caregiver, if applicable, Mini Zarit Caregiver Burden Scale, for the caregiver, if applicable, Cornell Scale for Depression in Dementia, Quality of Life in Alzheimer's Disease, Neuropsychiatric Inventory
Administration of individualized advice	Neuropsychiatric Inventory (Cummings)	Administration of individualized advice to improve the quality of older people's sleep, based on the following interventions : Pittsburgh Sleep Quality Index, Sleep diary, Mini Mental State Examination, Autonomy assessment (Katz Index of Independence in Activities of Daily Living \& Lawton Instrumental Activities of Daily Living), Neuropsychiatric Inventory (Cummings) for the caregiver, if applicable, Mini Zarit Caregiver Burden Scale, for the caregiver, if applicable, Cornell Scale for Depression in Dementia, Quality of Life in Alzheimer's Disease, Neuropsychiatric Inventory
Administration of individualized advice	Pittsburgh Sleep Quality Index	Administration of individualized advice to improve the quality of older people's sleep, based on the following interventions : Pittsburgh Sleep Quality Index, Sleep diary, Mini Mental State Examination, Autonomy assessment (Katz Index of Independence in Activities of Daily Living \& Lawton Instrumental Activities of Daily Living), Neuropsychiatric Inventory (Cummings) for the caregiver, if applicable, Mini Zarit Caregiver Burden Scale, for the caregiver, if applicable, Cornell Scale for Depression in Dementia, Quality of Life in Alzheimer's Disease, Neuropsychiatric Inventory
Administration of individualized advice	Sleep diary	Administration of individualized advice to improve the quality of older people's sleep, based on the following interventions : Pittsburgh Sleep Quality Index, Sleep diary, Mini Mental State Examination, Autonomy assessment (Katz Index of Independence in Activities of Daily Living \& Lawton Instrumental Activities of Daily Living), Neuropsychiatric Inventory (Cummings) for the caregiver, if applicable, Mini Zarit Caregiver Burden Scale, for the caregiver, if applicable, Cornell Scale for Depression in Dementia, Quality of Life in Alzheimer's Disease, Neuropsychiatric Inventory
Administration of individualized advice	Mini Zarit Caregiver Burden Scale, for the caregiver	Administration of individualized advice to improve the quality of older people's sleep, based on the following interventions : Pittsburgh Sleep Quality Index, Sleep diary, Mini Mental State Examination, Autonomy assessment (Katz Index of Independence in Activities of Daily Living \& Lawton Instrumental Activities of Daily Living), Neuropsychiatric Inventory (Cummings) for the caregiver, if applicable, Mini Zarit Caregiver Burden Scale, for the caregiver, if applicable, Cornell Scale for Depression in Dementia, Quality of Life in Alzheimer's Disease, Neuropsychiatric Inventory
Administration of individualized advice	Cornell Scale for Depression in Dementia	Administration of individualized advice to improve the quality of older people's sleep, based on the following interventions : Pittsburgh Sleep Quality Index, Sleep diary, Mini Mental State Examination, Autonomy assessment (Katz Index of Independence in Activities of Daily Living \& Lawton Instrumental Activities of Daily Living), Neuropsychiatric Inventory (Cummings) for the caregiver, if applicable, Mini Zarit Caregiver Burden Scale, for the caregiver, if applicable, Cornell Scale for Depression in Dementia, Quality of Life in Alzheimer's Disease, Neuropsychiatric Inventory
Administration of individualized advice	Mini Mental state examination	Administration of individualized advice to improve the quality of older people's sleep, based on the following interventions : Pittsburgh Sleep Quality Index, Sleep diary, Mini Mental State Examination, Autonomy assessment (Katz Index of Independence in Activities of Daily Living \& Lawton Instrumental Activities of Daily Living), Neuropsychiatric Inventory (Cummings) for the caregiver, if applicable, Mini Zarit Caregiver Burden Scale, for the caregiver, if applicable, Cornell Scale for Depression in Dementia, Quality of Life in Alzheimer's Disease, Neuropsychiatric Inventory
Administration of individualized advice	Quality of Life in Alzheimer's Disease	Administration of individualized advice to improve the quality of older people's sleep, based on the following interventions : Pittsburgh Sleep Quality Index, Sleep diary, Mini Mental State Examination, Autonomy assessment (Katz Index of Independence in Activities of Daily Living \& Lawton Instrumental Activities of Daily Living), Neuropsychiatric Inventory (Cummings) for the caregiver, if applicable, Mini Zarit Caregiver Burden Scale, for the caregiver, if applicable, Cornell Scale for Depression in Dementia, Quality of Life in Alzheimer's Disease, Neuropsychiatric Inventory

Primary Outcome Measures

Name	Time	Method
Evaluation of the benefits of individualized advice administration on sleep quality for the elderly living at home and complaining about their sleep	Through study completion, an average of 6 months	Evolution of the Pittsburgh Sleep Quality Index. The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

Secondary Outcome Measures

Name	Time	Method
Impact of a specific follow-up on quantity of sleep of elderly complaining about their sleep	Through study completion, an average of 6 months	Review of the sleep diaries to evaluate the impact on the quantity of sleep
Impact of a specific follow up on the burden of caregivers of elderly complaining about their sleep	Through study completion, an average of 6 months	Evolution of the 7 item Zarit Care Burden Interview scale score. Points are assigned to each items as follows : never=0; sometimes=0,5 ; often=1 Total score is the sum of all items, 0-2 : Little or no burden 2-3,5: Mild to moderate burden 3,5-5,5: Moderate to severe burden 5,5-7: Severe burden
Impact of a specific follow up on quality of life of caregivers of elderly complaining about their sleep	Through study completion, an average of 6 months	Evolution of the Quality of Life in Alzheimer's Disease questionnaire score : The QOL-AD is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life from both the patient and the caregiver. Caregivers complete the measure as a questionnaire about their patients' Quality Of Life, while patients complete it in interview format about their own Quality Of Life. The measure consists of 13 items, rated on a four point scale, with 1 being poor and 4 being excellent. Total scores range from 13 to 52.
Impact of a specific follow up on quality of life of elderly complaining about their sleep	Through study completion, an average of 6 months	Evolution of the psychotropic drug consumption (how many and which type)

Trial Locations

Locations (1)

GHRMSA; 🇫🇷 Mulhouse, France