Efficiency of a Nursing Intervention in Sleep Hygiene in Prediabetes and Diabetes Mellitus 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Change of glycated hemoglobin levels.
Study Overview
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.
Detailed Description
Several studies have shown the association between short and poor sleep quality and alterations in glucose metabolism as well as the appearance of insulin resistance phenomena. This issue makes the research on this subject relevant to establish interventions aimed at improving the quality of sleep. Nursing professionals in the field of Primary Care have a decisive role in the monitoring and control of chronic diseases, among which DM2 stands out due to its high prevalence, great morbidity and mortality and healthcare pressure. Therefore, it is necessary to check the efficiency of healthy sleep hygiene to carry out prevention and achieve good metabolic control of the patient. Therefore, it is, in this way, important to prevent the development of the disease in the case of patients with prediabetes and the appearance of complications in patients with DM2.
Therefore, the overall objective is to determine the efficiency 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 DM2 or prediabetes.
The specific objectives are:
- Describe the mean and range of hours that patients with DM2 or prediabetes declare to sleep.
- To analyse the assessment of the quality of sleep referred by people with DM2 or prediabetes through the PSQI.
- Calculate the correlation between the number of hours of sleep declared and the HbA1c values.
- Compare the amount and quality of sleep and HbA1c value in the control group and the experimental group.
In the other hand, the hypotesis are:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 Outcomes
- Change in sleep quality: Pittsburgh Sleep Quality Index(Three months.)
Investigators
Cristina García Serrano
Nurse of Primary Care
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina