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
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
|Study Type :||Interventional|
|Estimated Enrollment :||100 participants|
|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|
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:
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.
- 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.
- 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.
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
|Contact: Cristina García Serrano, Nurse||973447714 ext +email@example.com|
|Contact: Jesús Pujol Salud, Doctor||973447714 ext +firstname.lastname@example.org|
|Centro Atención Primaria - Institut Català de la Salut||Recruiting|
|Balaguer, Lleida, Spain, 25600|
|Contact: Cristina García Serrano, Nurse 973447714 ext +34 email@example.com|
|Contact: Jesús Pujol Salud, Doctor 973447714 ext +34 firstname.lastname@example.org|
|Principal Investigator: Cristina García Serrano, Nurse|
|Principal Investigator: Lídia Aran Solé, Nurse|
|Principal Investigator: Jesús Pujol Salud, Doctor|
|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|