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

NCT03594851 | Completed

• 2 other identifiers: GHR 924ID RCB 2017-A02815-48
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder; Complaint, Subjective Health

Keywords

quality of sleep; elderly; health education; quantity of sleep; caregiver's burden

Outcome Measures

Primary Outcomes (1)

• Evaluation of the benefits of individualized advice administration on sleep quality for the elderly living at home and complaining about their sleep

  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.

  Through study completion, an average of 6 months

Secondary Outcomes (11)

• Impact of a specific follow-up on quantity of sleep of elderly complaining about their sleep

  Through study completion, an average of 6 months

• Impact of a specific follow up on quality of life of elderly complaining about their sleep

  Through study completion, an average of 6 months

• Impact of a specific follow up on quality of life of elderly complaining about their sleep

  Through study completion, an average of 6 months

• Impact of a specific follow up on quality of life of elderly complaining about their sleep

  Through study completion, an average of 6 months

• Impact of a specific follow up on quality of life of elderly complaining about their sleep

  Through study completion, an average of 6 months

Study Arms (1)

Administration of individualized advice

EXPERIMENTAL

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

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

Interventions

Pittsburgh Sleep Quality Index BEHAVIORAL

The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.

Also known as: PSQI

Administration of individualized advice

Sleep diary BEHAVIORAL

A sleep diary is a record of a patient's sleep patterns and habits that can be extremely useful in helping doctors make a diagnosis of a sleep disorder and better determine if a sleep study should be prescribed.

Administration of individualized advice

Katz Index of Independence in Activities of Daily Living BEHAVIORAL

Katz Activities of Daily Living is a validated tool to assess functional status as a measurement of the elder's ability to perform activities of daily living independently. Elders are scored yes/no for independence in each of six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less implies severe functional impairment.

Also known as: Katz ADL

Administration of individualized advice

Lawton Instrumental Activities of Daily Living BEHAVIORAL

Lawton's Instrumental Activities of Daily Living (IADL) scale was developed to assess more complex activities (termed "instrumental activities of daily living") necessary for functioning in community settings (e.g., shopping, cooking, managing finances). The capacity to handle these complex functions normally is lost before basic "activities of daily living" which are measured by Activities of Daily Living scales. Therefore, assessing Instrumental Activities of Daily Living may identify incipient decline in older adults who are otherwise capable and healthy.The Lawton Instrumental Activities of Daily Living scale takes approximately 10 to 15 minutes to administer. It contains 8 items that are rated with a summary score from 0 (low functioning) to 8 (high functioning). This scale can be administered through an interview or by a written questionnaire. The patient or a caregiver who is familiar with the patient can provide the answers.

Also known as: IADL

Administration of individualized advice

Neuropsychiatric Inventory (Cummings) BEHAVIORAL

Neuropsychiatric Inventory is submitted to the caregiver, if the patient has a Mini Mental State Examination score between 10 and 20. The Neuropsychiatric Inventory (NPI) was developed by Cummings et al. (1994) to assess dementia-related behavioral symptoms which they felt other measures did not sufficiently address. The NPI originally examined 10 sub-domains of behavioral functioning: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor activity. Two more sub-domains have been added since its development: night-time behavioral disturbances and appetite and eating abnormalities (Cummings, 1997). This wide variety of domains means that, unlike other dementia measures, the NPI is able to screen for multiple types of dementia, not just Alzheimer's Disease.

Also known as: NPI

Administration of individualized advice

Mini Zarit Caregiver Burden Scale, for the caregiver BEHAVIORAL

Mini Zarit Caregiver Burden Scale, for the caregiver, if the patient has a Mini Mental State Examination score between 10 and 20.

Administration of individualized advice

Mini Mental state examination BEHAVIORAL

It is an 11-question tool to evaluate cognitive functions. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The Mini Mental state examination takes only 5-10 minutes to administer and is therefore practical to use repeatedly and routinely. The MMSE has been validated and extensively used in both clinical practice and research, since its creation in 1975

Also known as: MMSE

Administration of individualized advice

Cornell Scale for Depression in Dementia BEHAVIORAL

The Cornell scale For Depression in Dementia is a scoring system specifically developed to assess signs and symptoms of major depression in patients with dementia. The 19 parameters measured are clustered into five groups: mood-related signs, behavioural disturbances, physical signs, cyclic functions and ideational disturbances. The Cornell scale For Depression in Dementia has been shown to be sensitive, reliable and valid for assessing depression in patients with Alzheimer's disease.

Administration of individualized advice

Quality of Life in Alzheimer's Disease BEHAVIORAL

The Quality of Life in Alzheimer's Disease 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. It was developed for individuals with dementia, based on patient, caregiver, and expert input, to maximize construct validity, and to ensure that the measure focuses on quality of life domains thought to be important in cognitively impaired older adults. It uses simple and straightforward language and responses \& includes assessments of the individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality

Also known as: QOL-AD

Administration of individualized advice

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient giving a signed informed consent
• Patient complaining about their sleep
• Patient living at home
• 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
• Patient able to fill in questionnaires

You may not qualify if:

• Patient living in a senior living facility
• Patient legally protected
• Patient with a psychotic decompensation
• Patient with a sleep pathology
• Patient with a Lewy body disease at the time of enrollment
• Patient with no health insurance

Sponsors & Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: lead

Study Sites (1)

GHRMSA

Mulhouse, 68100, France

Location

Related Publications (23)

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MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Health Education

Interventions

Activities of Daily Living; Mental Status and Dementia Tests; Quality of Life; Amyloid beta-Protein Precursor

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Amyloidogenic Proteins; Amyloid; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Protein Precursors; Protease Nexins; Proteinase Inhibitory Proteins, Secretory

Study Officials

• Anna Derajinski, MD

  Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Administration of individualized advice to older people living at home complaining of sleep disorders

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: July 20, 2018
• Study Start: January 8, 2018
• Primary Completion: July 8, 2019
• Study Completion: July 30, 2019
• Last Updated: August 21, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)