Developing and testing the feasibility of virtual nursing interventions in inpatient and outpatient hospital contexts to promote self-management by people with diabetes (Virtual Advanced Nursing Practice: PIAVIR)

Switzerland (ICTRP)

Identifiant de l'essai ICTRP
ISRCTN30640743 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
Understanding and Improving Patient Engagement in Self-management Behaviour through Virtual Nursing Interventions for Diabetes in Inpatient and Outpatient Clinics: a Development and Feasibility Study (PIAVIR) (BASEC)

Titre académique
Understanding and improving patient engagement in self-management behaviour through virtual nursing interventions for diabetes in inpatient and outpatient clinics: a development and feasibility study (ICTRP)

Titre public
A virtual nursing intervention for self-management education and support versus usual care in adults with diabetes: a feasibility randomised controlled trial (ICTRP)

Maladie en cours d'investigation
Diabetes mellitus, Type 1 diabetes mellitus, Type 2 patient education, health education educational support of self-management in adults
Nutritional, Metabolic, Endocrine (ICTRP)

Intervention étudiée
Current interventions as of 05/06/2025:
In the intervention arm, participants undertake a 6-month digital self-management intervention featuring 57 short educational videos covering topics such as: general information about diabetes, treatment with insulin, insulin injection techniques, blood glucose monitoring, hypo- and hyperglycaemia management, food choices, physical activity, living with diabetes, testimonials and coping strategies. They are encouraged to watch at least one video between regular clinic visits. Automated motivational emails are sent monthly to maintain engagement. After the 6-month active phase, participants retain access to the video library for another 6 months, but no longer receive reminder emails.

Participants assigned to the control group are placed on a 6-month waiting list, during which they continue to receive usual diabetes care, including standard clinical appointments, laboratory testing and ad-hoc telephone or email support. They do not have access to the educational videos while on the waiting list. After completing the 6-month control period, they gain access to the same intervention as the intervention group.

Previous interventions:
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 b (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Single-centre interventional open-label 6-month waiting list randomized controlled trial (Other) (ICTRP)

Critères d'inclusion/exclusion
Inclusion criteria: Current inclusion criteria as of 05/06/2025:
1. Written and signed informed consent
2. Aged =18 years
3. Diagnosed with diabetes type 1 or type 2
4. French- or German-speaking (with sufficient comprehension to participate in focus groups and complete questionnaires)
5. No current or planned attendance at any other structured diabetes education initiative
6. Being interested and accustomed to the use of technology (e.g., smartphone, tablets and internet)

Previous 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 (ICTRP)

Exclusion criteria: Current exclusion criteria as of 05/06/2025:
1. Severe physical/mental illness
2. Significant learning difficulties
3. Unable to give informed consent
4. Relatives of the study team (spouse, children, parents or siblings)

Previous exclusion criteria:
1. Severe physical/mental illness
2. Significant learning difficulties
3. Unable to give informed consent

Critères d'évaluation principaux et secondaires
Current primary outcome measures as of 05/06/2025:
1. Recruitment rate is measured using the proportion of eligible participants who consent to participate. Data sourced from the study recruitment log at baseline
2. Completion rate is measured using the proportion of participants who complete the intervention and follow-up assessments. Data recorded in the study database at 6 and 12 months
3. Acceptability of the intervention is measured using a participant feedback questionnaire developed based on the Technology Acceptance Model (TAM), covering perceived usefulness, ease of use, attitude toward use, and intention to use at 6 and 12 months
4. Usability of the intervention is measured using the same TAM-based participant feedback questionnaire, including Likert-scale items on orientation, clarity, and overall system satisfaction at 6 and 12 months

Previous primary outcome measures:
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 (ICTRP)

Current secondary outcome measures as of 05/06/2025:
1. Glycaemic control is measured using self-reported HbA1c values, verified with patient medical records, at baseline, 6 and 12 months
2. Diabetes self-efficacy is measured using the Diabetes Management Self-Efficacy Scale (CDSES) at baseline, 6 and 12 months
3. Chronic illness care experience is measured using the Patient Assessment of Chronic Illness Care (PACIC) questionnaire at baseline, 6 and 12 months
4. Diabetes-related emotional distress is measured using the Problem Areas in Diabetes Scale (PAID) at baseline, 6 and 12 months
5. Socioeconomic deprivation is measured using the Deprivation in Primary Care Questionnaire (DiPCare-Q) at baseline, 6 and 12 months
6. Digital health literacy is measured using the eHealth Literacy Scale (eHEALS) at baseline, 6 and 12 months.
7. General health literacy is measured using the European Health Literacy Survey Questionnaire (HLS-EU-Q) at baseline, 6 and 12 months
8. Diabetes self-management behaviors are measured using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire at baseline, 6 and 12 months
9. Emergency treatment events are measured as the number of emergency treatment episodes (severe hypoglycaemia, diabetic ketoacidosis, unplanned hospitalisation) based on patient records at baseline, 6 and 12 months

Previous secondary outcome measures:
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 (ICTRP)

Date d'enregistrement
31.03.2022 (ICTRP)

Inclusion du premier participant
01.08.2022 (ICTRP)

Sponsors secondaires
non disponible

Contacts supplémentaires
Claudia Huber, claudia.huber@hefr.ch, +41 264296130 (ICTRP)

ID secondaires
Nil known, Nil known, SNSF PT00P1_198985, SNCTP 000004677 (ICTRP)

Résultats-Données individuelles des participants
YesAvailable on request. Current IPD sharing plan as of 05/06/2025: De-identified and aggregated datasets will be made available upon reasonable request and after publication at a later date in accordance with the study�s data management plan. The researchers will add the details at a later date. Previous IPD sharing plan: The definitive data-sharing plans for the current study are unknown and will be made available at a later date. (ICTRP)

Informations complémentaires sur l'essai
https://www.isrctn.com/ISRCTN30640743 (ICTRP)