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Efficiency of a Nursing Intervention in Sleep Hygiene (ENISH)

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ClinicalTrials.gov Identifier: NCT03857802
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Cristina García Serrano, Jordi Gol i Gurina Foundation

Brief Summary:

Background: The relationship between the appearance of insulin resistance phenomena and insufficient or poor-quality sleep is scientifically documented.

Objectives: To determine the effectiveness of an intervention based on behavioural techniques on sleep in the nursing consultation in the Primary Care setting to improve the level of HbA1c in patients diagnosed with diabetes mellitus 2 (DM2) or prediabetes.

Hypothesis: Patients diagnosed with DM2 or prediabetes with poor sleep quality would improve their HbA1c levels after an intervention on healthier sleep hygiene practices. Sleeping 6 or less hours in adults diagnosed with DM2 or prediabetes would be related to worse metabolic control results. Patients diagnosed with DM2 or prediabetes who would value their sleep as poor quality would have poorer metabolic control.

Methodology: Design: Not masked randomized clinical trial. Target population: Patients diagnosed up to the time of DM2 (E11) or prediabetes (R73, R73.9) with age over 18 attending the chronic nurses' follow-up visits of the Basic Health Area of Balaguer in the time range from November 2017 to December 2018. Determinations: Dependent variables: Glycemia and HbA1c. Independent variables: Sex, age, value of the Pittsburgh Sleep Quality Index (PSQI), declared hours of sleep, sleep efficiency, body mass index (BMI), pharmacologic antidiabetic treatment, changes in it, changes in diet, physical exercise and sleep hygiene. Statistical analysis: Analysis of the comparability of the groups and calculation of the confidence interval of the difference in the glycaemic values and HbA1c at the end of the follow-up, with respect to the initiation within the intervention group and within the control, and control group with respect to the group intervention.


Condition or disease Intervention/treatment Phase
Sleep Disorder Metabolic Glucose Disorders Behavioral: Sleep hygiene intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental study, non-masked clinical trial of evaluation of an educational intervention in the field of Primary Care Nursing: Basic Health Area (BHA) of Balaguer. Two groups will be established randomly: experimental group and control group. In the experimental group will proceed to the explanation of sleep hygiene measures to improve the quality of sleep. In the control group, the same follow-up visits and the same blood extractions will be carried out, but no educational activity on sleep will be carried out.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Efficiency of a Nursing Intervention in Sleep Hygiene in Prediabetes and Diabetes Mellitus 2
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sleep hygiene intervention
In the experimental group will proceed to the explanation of sleep hygiene measures to improve the quality of sleep. After 3 months, at the next health check, the quality of sleep questionnaire will be carried out together with the blood extraction.
Behavioral: Sleep hygiene intervention

An individual education will be carried out following a bidirectional feedback method. It is intended to develop skills to make conscious and autonomous decisions. The explanation will consist:

  1. Information and reading with discussion of the educational sheet: The 9 tips for a healthy sleep will be read, point by point. The nurse will be open to discuss those that generate doubt.
  2. Confrontation: even if the patient does not ask any questions about it, it will be necessary to ask if he has understood the advice.
  3. Participated information: Questions will be asked to the patient such as: "Did you already know any of these tips?".

A telephone call per month will be made as an educational reinforcement to the intervention.


No Intervention: No sleep hygiene intervention
In the no intervention group, the same follow-up visits and the same blood extractions will be carried out, but no educational activity on sleep will be carried out.



Primary Outcome Measures :
  1. Change of glycated hemoglobin levels. [ Time Frame: Three months ]

    Change the level of HbA1c in patients diagnosed with DM2 or prediabetes by an intervention in sleep hygiene.

    The levels will be measured by blood test according to laboratory protocol.



Secondary Outcome Measures :
  1. Change in sleep quality: Pittsburgh Sleep Quality Index [ Time Frame: Three months. ]
    Sleep quality will be measured with the Pittsburgh Sleep Quality Index before and after the intervention. The score varies between 0 and 21 points. A higher score means a worse quality of sleep. A total score less or equal than to five indicates that the quality of sleep is optimal, while a total score greater than five suggests that you have sleep problems.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years.
  • Hb1Ac greater than or equal to 5.7% at the time of diagnosis.
  • PSQI greater than 5 points (poor sleep quality).
  • Acceptance of participation in the study.

Exclusion Criteria:

  • People diagnosed with:

    • Obstructive Sleep Apnea Syndrome.
    • Narcolepsy
    • Fibromyalgia
    • Dementias
    • Schizophrenia
    • Psychosis
    • Major depression
  • People with shift working hours.

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 ClinicalTrials.gov identifier (NCT number): NCT03857802


Contacts
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Contact: Cristina García Serrano, Nurse 973447714 ext +34 cristinagarse3@gmail.com
Contact: Jesús Pujol Salud, Doctor 973447714 ext +34 jpujol.lleida.ics@gencat.cat

Locations
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Spain
Centro Atención Primaria - Institut Català de la Salut Recruiting
Balaguer, Lleida, Spain, 25600
Contact: Cristina García Serrano, Nurse    973447714 ext +34    cristinagarse3@gmail.com   
Contact: Jesús Pujol Salud, Doctor    973447714 ext +34    jpujol.lleida.ics@gencat.cat   
Principal Investigator: Cristina García Serrano, Nurse         
Principal Investigator: Lídia Aran Solé, Nurse         
Principal Investigator: Jesús Pujol Salud, Doctor         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
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Principal Investigator: Cristina García Serrano, Nurse Institut Català de la Salut
Principal Investigator: Jesús Pujol Salud, Doctor Institut Català de la Salut
Principal Investigator: Lídia Aran Solé, Nurse Institut Català de la Salut

Additional Information:
Publications of Results:

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Responsible Party: Cristina García Serrano, Nurse of Primary Care, Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03857802     History of Changes
Other Study ID Numbers: JordiGol
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Once the study is completed, the study protocol and results will be published in a scientific journal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cristina García Serrano, Jordi Gol i Gurina Foundation:
diabetes mellitus type 2
prediabetic state
sleep hygiene
haemoglobin A glycosylated
clinical nursing research
Additional relevant MeSH terms:
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Sleep Wake Disorders
Glucose Metabolism Disorders
Disease
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Metabolic Diseases