A virtual nursing intervention for self-management education and support versus usual care in adults with diabetes: a feasibility randomised controlled trial
| ISRCTN | ISRCTN30640743 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30640743 |
| Secondary identifying numbers | SNSF PT00P1_198985, SNCTP 000004677 |
- Submission date
- 16/03/2022
- Registration date
- 31/03/2022
- Last edited
- 10/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Virtual interventions have beneficial effects on diabetes self-management, especially when they integrate components of patient education and support as essential parts of therapy. They are not yet widely implemented into usual patient care but have the potential to improve the delivery of continuous high-quality care. The study follows the phases of the Medical Research Council (MRC) framework for developing and evaluating complex interventions. The aim of this feasibility randomised controlled trial with a waiting-list control group is to evaluate the feasibility and acceptability of a virtual intervention of diabetes self-management education and support.
Who can participate?
Adults with type 1 or type 2 diabetes
What does the study involve?
Participants are recruited at a diabetes clinic and, after giving informed consent, are randomly assigned in a 1:1 ratio to either the intervention group or a 6-month waiting-list control group. The intervention consists of educational videos designed to support diabetes self-management between routine clinical visits. Participants are encouraged to watch at least one of the 57 short educational videos; they receive monthly reminder emails during the 6-month intervention period. The control group receives usual outpatient care for 6 months, then completes the same 6-month digital intervention as the intervention group. Sociodemographic, clinical, and psychosocial data are collected at baseline, 6 months, and 12 months; reasons for non-completion are documented. Feasibility and acceptability are assessed against predefined criteria addressing recruitment (enrolment rate), completion (retention rate), and participants’ perceived acceptability and implementability, including usability of the intervention via questionnaires and interviews at 6 and 12 months.
What are the possible benefits and risks of participating?
The virtual intervention is evaluated in terms of feasibility, acceptability, recruitment and completion rates. The benefits include providing better support to people with diabetes to help them improve their self-management behaviour through a video-based virtual intervention. The study poses a slight risk of participants having to reflect on experiences that could elicit strong emotions; otherwise, there are no physical or psychological risks to the participants' health.
Where is the study run from?
University of Applied Sciences and Arts Western Switzerland
When is the study starting and how long is it expected to run for?
April 2021 to September 2024
Who is funding the study?
Swiss National Science Foundation
Who is the main contact?
Claudia Huber, PhD, claudia.huber@hefr.ch
Contact information
Principal Investigator
Route des Arsenaux 16a
Fribourg
1700
Switzerland
 ORCID ID |
0000-0001-8471-6230 |
|---|---|
| Phone | +41 264296130 |
| claudia.huber@hefr.ch |
Scientific
Route des Arsenaux 16a
Fribourg
1700
Switzerland
| Phone | +41 264296130 |
|---|---|
| claudia.huber@hefr.ch |
Public
Route des Arsenaux 16a
Fribourg
1700
Switzerland
| Phone | +41 264296130 |
|---|---|
| claudia.huber@hefr.ch |
Study information
| Study design | Single-centre interventional open-label 6-month waiting list randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | 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 |
| Study acronym | PIAVIR |
| Study objectives | Current study hypothesis as of 05/06/2025: It is hypothesised that a virtual intervention (PIAVIR), which uses educational videos in addition to usual care, is feasible for supporting diabetes self-management in adults, as evidenced by recruitment, retention, acceptability, and usability in a randomised controlled trial. Previous study hypothesis: To test the feasibility of undertaking a randomised controlled trial of a virtual nursing intervention for self-mangement education and support (PIAVIR) versus usual care in adults with diabetes in inpatient and outpatient clinics |
| Ethics approval(s) | Approved 16/11/2021, Cantonal Commission for Ethics in Human Research of the Canton of Vaud (Commission cantonale (VD) d'éthique de la recherche sur l’être humain (CER-VD), Av. de Chailly 23. 1012 Lausanne, Switzerland; +41 (0)21 316 18 36; secretariat.cer@vd.ch), ref: BASEC 2021-01763 |
| Health condition(s) or problem(s) studied | Diabetes mellitus, Type 1; diabetes mellitus, Type 2; patient education, health education; educational support of self-management in adults |
| Intervention | 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 both groups. Computerised block randomisation with 1:1 allocation rate will be used. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2021 |
| Completion date | 10/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 60 |
| Total final enrolment | 54 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2022 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Fribourg
1708
Switzerland
Sponsor information
University/education
Route des Arsenaux 16a
Fribourg
1700
Switzerland
| Phone | +41 26 429 61 12 |
|---|---|
| derek.christie@hefr.ch | |
| Website | http://www.hes-so.ch/en/homepage-hes-so-1679.html |
"ROR" |
https://ror.org/01xkakk17 |
Funders
Funder type
Government
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 05/06/2025: Planned publication in peer-reviewed journals and international conferences. Previous publication and dissemination plan: Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | 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. |
Editorial Notes
10/06/2025: The plain English summary was updated.
05/06/2025: The following changes were made to the study record:
1. The public title was changed from 'A virtual nursing intervention for self-management education and support versus usual care in adults with diabetes' to 'A virtual nursing intervention for self-management education and support versus usual care in adults with diabetes: a feasibility randomised controlled trial'.
2. The plain English summary, study hypothesis, interventions, inclusion and exclusion criteria, and publication and dissemination plan, primary and secondary outcome measures, and IPD sharing plan were updated.
3. The study design was changed from 'Single-center interventional open-mask blinded 6-month waiting list randomized controlled trial' to 'Single-centre interventional open-label 6-month waiting list randomized controlled trial'.
4. The condition was changed from 'Education and support of self-management in adults with diabetes' to 'Diabetes mellitus, Type 1; diabetes mellitus, Type 2; patient education, health education; educational support of self-management in adults'.
5. The overall study end date was changed from 30/09/2024 to 10/09/2024.
6. The intention to publish date was changed from 31/05/2025 to 30/06/2025.
7. Total final enrolment added.
28/12/2023: The intention to publish date has been changed from 31/10/2024 to 31/05/2025.
27/12/2023: The overall study end date has been changed from 31/12/2023 to 30/09/2024 and the plain English summary updated accordingly.
09/03/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/07/2022 to 01/08/2022.
2. The recruitment end date was changed from 31/12/2022 to 31/03/2023.
11/10/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/10/2023 to 31/12/2023.
2. The recruitment start date was changed from 01/06/2022 to 01/07/2022.
3. The recruitment end date was changed from 31/10/2022 to 31/12/2022.
4. The plain English summary was updated to reflect these changes.
16/05/2022: The recruitment start date has been changed from 01/05/2022 to 01/06/2022.
31/03/2022: Trial's existence confirmed by Cantonal Commission for Ethics in Human Research of the Canton of Vaud.
