Efficiency of a Nursing Intervention in Sleep Hygiene

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.

Conditions

• Sleep Disorder
• Metabolic Glucose Disorders

Interventions

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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  lead OTHER

Principal Investigators

• Cristina García Serrano, Nurse · Institut Català de la Salut

• Jesús Pujol Salud, Doctor · Institut Català de la Salut

• Lídia Aran Solé, Nurse · Institut Català de la Salut

• Joaquim Sol, MSc · Institut Català de la Salut-IDIAP Jordi Gol

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-01

Primary Completion

2018-12-15

Completion

2020-01-10

Countries

• Spain

Study Locations