A virtual nursing intervention for self-management education and support versus usual care in adults with diabetes

Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: We aim to evaluate the feasibility of the PIAVIR intervention which is a virtual nursing intervention that incorporates at least one of the 48 video capsules for diabetes education of type 1 or type 2 diabetes. The virtual support of video capsules will be added between regularly scheduled clinical visits and complemented with options of direct exchange via text message or phone call if there is any uncertainty. Usual care involves out‐patient consultations until exposure to the intervention at 6 months. To minimise potential external contamination, other educational interactions will be monitored in both groups. Computerised block randomisation with 1:1 allocation rate will be used. CONDITION: Education and support of self‐management in adults with diabetes ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: ; Feasibility outcomes:; 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 6 months; 2. Retention/attrition rates recorded as the number of participants remaining in the study at 0, 6 and 12 months; 3. Adherence to data collection plan recorded as the percentage of completed study measures; 4. Adherence to the intervention recorded as the number of recommended and participants’ actual use of the virtual intervention; 5. Participants perceived acceptability recorded as the level of appropriateness and usefulness of the intervention using questionnaires and interviews; ; Primary clinical outcome:; 6. HbA1c recorded as the number of patients achieving HbA1c‐values in the set target range and the mean differences between groups at 6 and 12 months; SECONDARY OUTCOME: ; 1. Self‐efficacy measured using the Chronic Disease Self‐Efficacy Scales (CDSES) at baseline, 6 and 12 months; 2. Self‐care management behaviour measured using the Summary of Diabetes Self‐Care Activities (SDSCA) at baseline, 6 and 12 months; 3. Diabetes‐related emotional distress measured using the Problem Areas in Diabetes Scale (PAID) at baseline, 6 and 12 months; 4. Patient reports of received care measured using Patient‐Assessed Chronic Illness Care (PACIC) at baseline, 6 and 12 months; 5. Health literacy measured using the European Health Literacy Survey Questionnaire (HLS‐EU‐Q) at baseline, 6 and 12 months; 6. Ability in using information technology for health measured using the eHealth literacy scale (eHEALS) at baseline, 6 and 12 months; 7. Perceived level of deprivation measured using the Deprivation in Primary Care Questionnaire (DiPCare‐Q) at baseline, 6 and 12 months; 8. Emergency care events recorded as the number of emergency care events (severe hypoglycaemia, diabetic ketoacidosis, unplanned hospitalisations) throughout the study; INCLUSION CRITERIA: 1. Aged =18 years 2. Diagnosed with diabetes type 1 or type 2 3. No current or planned attendance at any other structured diabetes education initiative 4. Being interested and accustomed to the use of technology
Epistemonikos ID: 0b87cf7dca0195b30e2409184032342bd7463ef0
First added on: Aug 25, 2024