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A web-based self management programme (HeLP-Diabetes) for people with type 2 diabetes in primary care

Randomised controlled trial of a web-based self management programme (HeLP-Diabetes) for people with type 2 diabetes in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN02123133
Enrollment
398
Registered
2013-02-14
Start date
2013-03-01
Completion date
Unknown
Last updated
2018-09-24

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

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Comparator website: This will be an information only website created by the study team to compare with HeLP-Diabetes HeLP-Diabetes: HeLP-Diabetes is a web-based self-management programme we have deve

Sponsors

University College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults, male and female, aged 18 or over 2. With type 2 diabetes

Exclusion criteria

Exclusion criteria: 1. Unable to provide informed consent, e.g. due to psychosis, dementia or severe learning difficulties 2. Terminally ill with less that 12 months life expectancy 3. Unable to use a computer due to severe mental or physical impairment 4. Insufficient mastery of spoken English to use the intervention 5. Current participation in a trial of an alternative self-management programme

Design outcomes

Primary

MeasureTime frame
Glycaemic control (HbA1c) and health-related quality of life, measured by the Problem Areas in Diabetes (PAID) scale Timepoint(s): Baseline, 3 months, 12 months

Secondary

MeasureTime frame
1. Body mass index (BMI); Timepoint(s): Baseline, 3 months, 12 months 2. Completion of "9 essential processes"; Timepoint(s): 12 months 3. Cost of developing intervention; Timepoint(s): Baseline, 3 months, 12 months 4. Cost of supported access; Timepoint(s): Baseline, 3 months, 12 months 5. Costs of maintaining and updating the intervention; Timepoint(s): Baseline, 3 months, 12 months 6. Costs of training NHS staff in using intervention and training patients to use intervention; Timepoint(s): Baseline, 3 months, 12 months 7. Disability Management Self Efficacy Scale (DMSES); Timepoint(s): Baseline, 3 months, 12 months 8. Diabetes Treatment Satisfaction Questionnaire change version (DTSQc); Timepoint(s): 12 months 9. DTSQs; Timepoint(s): Baseline, 3 months, 12 months 10. EQ-5D to calculate Quality-Adjusted Life Years (QALYs); Timepoint(s): Baseline, 3 months, 12 months 11. Hospital Anxiety and Depression Scale (HADS); Timepoint(s): Baseline, 3 months, 12 months 12. Health service utilisation during the study period; Timepoint(s): Baseline, 3 months, 12 months 13. Systolic and diastolic blood pressure; Timepoint(s): Baseline, 3 months, 12 months 14. Total cholesterol and HDL; Timepoint(s): Baseline, 3 months, 12 months 15. Use of website; Timepoint(s): Throughout

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026