Diabetes, Sleep disorders Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diabetes mellitus 2. Adults >18 years old 3. Men and women 4. Ability to give informed consent, and complete study
Exclusion criteria
Exclusion criteria: Current or concomitant illness that would interfere with the individual?s ability to perform the study or confound the study results. For PRIDE 2 and 3, type 1 diabetes patients will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In PRIDE 1 a questionnaire booklet will be issued to all patients willing to take part. It contains the following measures: EQ5D, stanford presenteeism scale, Mental Health Inventory (MHI5), Problem Areas in Diabetes (PAID) score, International Physical Activity Questionnaire (IPAQ), Pittsburgh Sleep Quality Index (PSQI), Berlin Questionnaire, Epworth Sleepiness Scale (ESS), Food Frequency Questionnaire (FFQ) and some healthcare utilisation measures. The questionnaire also includes the following descriptive variables: age at diabetes diagnosis, ethnicity, marital status, education level, dependents, family history, employment, smoking status, alcohol intake, comorbidities, and whether someone has accessed online health information. Further descriptive data on the participants will be gathered from their GP records. These will include: height, weight, waist circumference, blood pressure, blood glucose. In PRIDE 2 the following additional measurements will be taken from those selected to be part of this phase: variety of medication intake, sleep duration, ApneaHypopnea Index (AHI), cortisol, renal impairment stage, physical activity level, diabetic neuropathy stage, amount of dietary intake, past weight, past waist and neck circumference, past blood pressure, past albumin creatinine ratio, coping strategies level, depression and anxiety level, locus of control, impulsivity and cognitive function, readiness to change and the Functional Outcomes of Sleep Questionnaire (FOSQ) score. In PRIDE 3 the main outcomes will be: patients? current priorities in their lives, patients? account of the impact of unemployment on selfmanagement, patients? account of the impact of diagnosis on selfesteem, identity, ?candidacy?, and stigma, patients? perceptions of risk regarding the complications of type 2 diabetes, patients? views and perspectives on sleep and patients? views, understanding and perceptions of current service provision, i | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
England, United Kingdom