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ISRCTN
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ISRCTN76746689
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DOI
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10.1186/ISRCTN76746689
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Primary care Research Into Diabetes Evolution (PRIDE)
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Scientific title
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Prospective study of the long-term outcomes of diabetes and its complications. [Primary care Research Into Diabetes Evolution (PRIDE)]
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Acronym
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PRIDE
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Serial number at source
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Vrs 1.1
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Study hypothesis
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This is an exploratory, hypothesis-generating study.
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Lay summary
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Lay summary under review 2
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Ethics approval
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NRES Committee West Midlands - Solihull
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Study design
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Prospective cohort study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Diabetes, Sleep disorders
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Participants - inclusion criteria
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1. Diabetes mellitus
2. Adults >18 years old
3. Men and women
4. Ability to give informed consent, and complete study
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Participants - exclusion criteria
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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.
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Anticipated start date
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18/01/2012
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Anticipated end date
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01/08/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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PRIDE 1: potential 15000. PRIDE 2: 1000. PRIDE 3: 40
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Interventions
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This is observational research and does not include any interventions.
The study will be conducted in three phases.
PRIDE 1: patients will be asked to complete a comprehensive questionnaire that aims to find out health status and behaviours.
PRIDE 2: A subset of 1000 consenting patients with type 2 diabetes from PRIDE 1 will be randomly selected and invited to come for additional tests for a more comprehensive data collection and characterisation.
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Primary outcome measure(s)
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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, including diabetes self management education, and preferences for future diabetes care.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRC) for Birmingham & Black Country - Theme 8 (UK)
ResMed (UK)
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Trial website
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Publications
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Contact name
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Dr
Shahrad
Taheri
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Address
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University of Birmingham
Public Health Building
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B12 2TT
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Country
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United Kingdom
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Email
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s.taheri@bham.ac.uk
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Sponsor
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University of Birmingham (UK)
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Address
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Research Governance and Ethics
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Sponsor website:
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http://www.birmingham.ac.uk/
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Date applied
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29/11/2011
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Last edited
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30/11/2012
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Date ISRCTN assigned
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30/11/2012
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