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

August 20, 2019 updated by: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Evaluation of the Benefits of Individualized Advice Administration on Quality of Sleep for the Elderly Living at Home Prospective, Monocentric and Open Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Mulhouse, France, 68100
        • GHRMSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Administration of individualized advice

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
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.
Other Names:
  • PSQI
Behavioral: Sleep diary
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.
Behavioral: Katz Index of Independence in Activities of Daily Living
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.
Other Names:
  • Katz ADL
Behavioral: Lawton Instrumental Activities of Daily Living
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.
Other Names:
  • IADL
Behavioral: Neuropsychiatric Inventory (Cummings)

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.

Other Names:
  • NPI
Behavioral: Mini Zarit Caregiver Burden Scale, for the caregiver
Mini Zarit Caregiver Burden Scale, for the caregiver, if the patient has a Mini Mental State Examination score between 10 and 20.
Behavioral: Mini Mental state examination

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

Other Names:
  • MMSE
Behavioral: Cornell Scale for Depression in Dementia
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.
Behavioral: Quality of Life in Alzheimer's Disease
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
Other Names:
  • QOL-AD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the benefits of individualized advice administration on sleep quality for the elderly living at home and complaining about their sleep
Time Frame: 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.
Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of a specific follow-up on quantity of sleep of elderly complaining about their sleep
Time Frame: Through study completion, an average of 6 months
Review of the sleep diaries to evaluate the impact on the quantity of 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
Time Frame: Through study completion, an average of 6 months
Evolution of the Mini Mental state examination score : Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment
Through study completion, an average of 6 months
Impact of a specific follow up on quality of life of elderly complaining about their sleep
Time Frame: Through study completion, an average of 6 months
Evolution of the frequency of the patient's falls
Through study completion, an average of 6 months
Impact of a specific follow up on quality of life of elderly complaining about their sleep
Time Frame: Through study completion, an average of 6 months
Evolution of the Cornell Scale for Depression in Dementia score : The interviews focus on depressive symptoms and signs occurring during the week preceding the interview. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added. Scores above 10 indicate a probable major depression; scores above 18 indicate a definite major depression; scores below 6 as a rule are associated with absence of significant depressive symptoms.
Through study completion, an average of 6 months
Impact of a specific follow up on quality of life of elderly complaining about their sleep
Time Frame: Through study completion, an average of 6 months
Evolution of the Quality of Life in Alzheimer's Disease questionnaire score : The Quality Of Life - Alzheimer Disease questionnaire 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.
Through study completion, an average of 6 months
Impact of a specific follow up on quality of life of elderly complaining about their sleep
Time Frame: Through study completion, an average of 6 months
Evolution of the Instrumental Activities of Daily Living questionnaire scores : 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.
Through study completion, an average of 6 months
Impact of a specific follow up on quality of life of elderly complaining about their sleep
Time Frame: Through study completion, an average of 6 months
Evolution of the Katz Activities of Daily Living scores : 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.
Through study completion, an average of 6 months
Impact of a specific follow up on quality of life of elderly complaining about their sleep
Time Frame: Through study completion, an average of 6 months
Evolution of the Neuropsychiatric Inventory score. The Neuropsychiatric Inventory uses a structured, caregiver-based interview format to assess 10 behavioral domains (Delusions, Hallucinations, Agitation, Dysphoria, Anxiety, Apathy, Irritability, Euphoria, Disinhibition, and Aberrant motor behavior). Two additional domains (Nighttime behavioral disturbance, and Appetite/weight changes) are often added. The presence of problematic behaviors in each domain is assessed by asking an informant a screening question followed by a series of yes/no questions. The caregiver or surrogate reporter is then asked to rate the frequency of occurrence of that domain of behaviors. The same behaviors are then rated on level of severity (1 = mild, 2 = moderate, 3 = severe). The domain total score is the product of the frequency score multiplied by the severity score for that behavioral domain. A Neuropsychiatric Inventory total score is obtained by summing all the individual domain total scores.
Through study completion, an average of 6 months
Impact of a specific follow up on quality of life of elderly complaining about their sleep
Time Frame: Through study completion, an average of 6 months
Evolution of the psychotropic drug consumption (how many and which type)
Through study completion, an average of 6 months
Impact of a specific follow up on quality of life of caregivers of elderly complaining about their sleep
Time Frame: 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.
Through study completion, an average of 6 months
Impact of a specific follow up on the burden of caregivers of elderly complaining about their sleep
Time Frame: 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
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Investigators

  • Principal Investigator: Anna Derajinski, MD, Groupe hospitalier de la région de Mulhouse et Sud Alsace

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

July 8, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHR 924
  • ID RCB 2017-A02815-48 (Registry Identifier: Agence Nationale de Sécurité du Médicament et des Produits de Santé)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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