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Overcoming psychological stress to injections for type 2 diabetes

Impact of structured education on psychological stress to overcome a barrier to injectable treatment for type 2 diabetes: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16710901
Enrollment
150
Registered
2015-08-21
Start date
2015-08-03
Completion date
Unknown
Last updated
2018-08-20

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 Type 2 Diabetes Mellitus

Interventions

Phase 1 Four focus groups, assembled from each of the three study sites, will be explored to inform the development of the content of an education programme. Three of which will be comprised of peop

Sponsors

Ulster University
Lead Sponsor
Western Health and Social Care Trust
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Phase 1 1. Type 2 diabetes =1 year. 2. Aged between 25 and 75 3. Commencement of insulin or GLP-1 receptor agonist within the previous 12 months from the date of the audit 4. Refusal of insulin or GLP-1 receptor agonist within the previous 12 months from the date of the audit Phase 2 1. Type 2 diabetes diagnosed = 1 year 2. Aged between 25 and 75 3. HbA1c = 58 mmol/mol and =90 mmol/mol. 4. Transfer from oral hypoglycaemic treatment to injectable therapy judged appropriate by the consulting physician

Exclusion criteria

Exclusion criteria: Phase 2 1. Newly diagnosed type 2 diabetes 90 mmol/mol 4. Patients undergoing retinal photocoagulation therapy or dialysis treatment 5. Those currently in receipt of psychiatry or clinical psychology input 6. Within 3 months of undergoing a major event including MI, stroke and major surgery 7. Within 3 months of diagnosis or treatment of a major coexisting medical condition

Design outcomes

Primary

MeasureTime frame
Change from baseline between control and intervention group in the Problems Areas in Diabetes Scale (PAID). This will be measured at baseline (week 0 / first contact following consent to participate), week 12 and week 24.

Secondary

MeasureTime frame
Change from baseline in the Hospital Anxiety and Depression Scale (HADS), the Pearlin Mastery scale, the Diabetes Empowerment Scale - short form (DES-SF), nutritional intake, HbA1c, lipid profile, body weight, BMI. This will be measured at baseline (week 0 / first contact following consent to participate), week 12 and week 24.

Countries

United Kingdom

Contacts

Public ContactDeirdre McCay

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026