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HypoAware: A combined group and online educational program for diabetes patients with problematic hypoglycemia. A cost-effectiveness Randomized Controlled Trial.

HypoAware: A combined group and online educational program for diabetes patients with problematic hypoglycemia. A cost-effectiveness Randomized Controlled Trial. - HypoAware

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40352
Enrollment
160
Registered
2014-03-17
Start date
2014-03-04
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

juvenile diabetes type 1 diabetes type 2 diabetes

Interventions

HypoBewust: a 4 week blended group/online psycho-educational intervention aimed at improving patients* skills in detecting, treating, predicting, preventing and coping with hypoglycemia. Care as usu

Sponsors

Medische Psychologie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Type 1 or type 2 diabetes, 3 or more injections/day or pumptherapy, 18-70 years, 1 or more episodes of severe hypoglycemia in the past 2 years AND/OR impaired hypoglycemia awareness

Exclusion criteria

Exclusion criteria: Pregnancy, severe mental or physical disorders, not fluent in Dutch, no access to the Internet

Design outcomes

Primary

MeasureTime frame
Primary health related outcome • Frequency of severe hypoglycemia

Secondary

MeasureTime frame
Secondary health related outcomes • Frequency of mild hypoglycemia • Hypoglycemia Awareness • Glycosylated Hemoglobin (HbA1c) • Psychological measures: fear of hypoglycemia, diabetes-related distress, health-related quality of life, anxiety and depression, confidence in diabetes self-care Cost-effectiveness outcomes • Quality-adjusted life-years (QALY*s) • Health care consumption: test strip usage, outpatient visits, calls or emails, ER visits, ambulance transfers, hospital admissions • Participation: absenteeism from paid and unpaid work

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)