No registrations found.
ID
Source
Health condition
Diabetes, Hypoglycemia, Hypoglycaemia, Hypoglykemie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary health related outcome
• Frequency of severe hypoglycemia
Secondary outcome
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
Background summary
SUMMARY
Rationale:
Hypoglycemia poses an immediate burden on the person, as well as the health care system and society. While our intervention will generate costs, we propose that we can reduce direct and indirect costs with our intervention compared to care as usual by means of reducing (severe) hypoglycemia and improving related psychosocial well-being.
Objective:
To test the cost-effectiveness of the psycho-educational intervention HypoBewust (HB)
compared to care as usual.
Research questions:
1) Does HB significantly improve a) health related outcomes and b) societal costs?
2) Are the expected improvements of HB maintained from 6 to 12 months follow-up?
Study design:
Economic evaluation in a cluster RCT with measurements at baseline, 2, 4 and 6 months follow up for the intervention and control group and an additional 12 months for the intervention group to examine the possible effects over time.
Study population:
Adult insulin treated diabetes patients with severe hypoglycemia and/or impaired
hypoglycemia-awareness
Intervention:
HypoAware: 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 usual: 1-3 extra diabetes nurse/dietician appointments and telephone/email contact aimed at reducing hypoglycemia.
Main study parameters/endpoints:
Primary health related outcome
• Frequency of severe hypoglycemia
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
Study objective
Hypoglycemia poses an immediate burden on the person, as well as the health care system and society. While our intervention HypoAware (HA) will generate costs, we propose that we can reduce direct and indirect costs with our intervention compared to care as usual by means of reducing (severe) hypoglycemia and improving related psychosocial well-being. To test our hypothesis of superiority, we will conduct a cluster multicenter RCT with
measurements at baseline and 2, 4, 6 and (for the intervention group only) 12 months follow up.
1) We expect significantly larger improvements in the HA group relative to care as usual (the control condition) at 6 months follow-up:
a) In terms of health related outcomes: a reduction in frequency of 1) severe hypoglycemia and 2) an improvement in quality of life
b) In terms of cost-effectiveness: a significant reduction in societal costs due to a reduction of sick leave and health care consumption.
2) We expect anticipated improvements in the HA group in health related outcomes and cost effectiveness to be maintained from 6 months to 12 months follow-up in the intervention group.
Study design
Measurements at baseline, 2, 4 and 6 months
follow up for the intervention and control group and an additional 12 months for the
intervention group to examine the possible effects over time.
Intervention
HypoAware: 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 usual: 1-3 diabetes nurse/dietician appointments and telephone/email contact aimed at reducing hypoglycemia.
Medical Faculty, room D-342
Van der Boechorststraat 7
S. Rondags
Amsterdam 1081 BT
The Netherlands
0031(0)204448352
s.rondags@vumc.nl
Medical Faculty, room D-342
Van der Boechorststraat 7
S. Rondags
Amsterdam 1081 BT
The Netherlands
0031(0)204448352
s.rondags@vumc.nl
Inclusion criteria
Patients are eligible for the study if they have had at least 1 episode of severe hypoglycemia in the past 2 years and/or have subjective impaired hypoglycemia awareness. Other inclusion criteria are: adult (18 years or older), T1DM or T2DM on Multiple Daily Injections (3 or more daily) or Continuous Subcutaneous Insulin Infusion (pump). Patients should have access to the Internet and be willing and able to actively attend the 3 group meetings.
Exclusion criteria
Exclusion criteria: insufficient in Dutch language, pregnancy, serious medical co morbidity (e.g. cancer, dialysis), major psychiatric disorder (schizophrenia, bipolar depression), drug abuse, and severe visual or cognitive impairment.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4318 |
| NTR-old | NTR4538 |
| CCMO | NL47354.029.13 |
| OMON | NL-OMON40352 |