A virtual nursing intervention for self-management education and support versus usual care in adults with diabetes
| 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
- 28/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
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 level of continuous high-quality care delivery. The study follows the phases of the Medical Research Council (MRC) framework of 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 the recently developed 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 asked to join this study while they are at a diabetes clinic. After informed consent and inclusion in the study, the participants will be randomly allocated into the intervention group or the 6-month waiting control group. The intervention exposure will be the use of the virtual intervention that will be added between regularly scheduled clinical visits. Sociodemographic data, clinical data, and patient-reported psychosocial outcomes will be collected at baseline, at 6 and 12 months of the intervention. The intervention group will be exposed to the intervention over 6 months and then followed up for 6 months after the intervention (in total 12 months). After the 6-month waiting time for the control group, the participants of the control group will be exposed to the intervention over 6 months and then followed up for 6 months after the intervention. The 6-month follow-up post exposure of all participants will allow the investigation of sustainability of the intervention effects over time. Non-completers of the study will be evaluated for the underlying reasons. The feasibility and acceptability of the intervention will be assessed at 6 and 12 months of the intervention using questionnaires and focus groups with patients and healthcare professionals.
What are the possible benefits and risks of participating?
On completion of this study, the virtual intervention will be evaluated and tested in relation to its acceptability, implementability, recruitment, and completion rates. The benefits include better support of people with diabetes to improve their self-management behaviour through an optimised virtual intervention. The study presents a small potential risk of having to reflect upon experiences that could elicit strong emotions, otherwise, there are no physical or psychological risks to the health of participants.
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 center interventional open-mask blinded 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 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 |
| Condition | Education and support of self-management in adults with diabetes |
| 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. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 | 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 |
| Overall study end date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 60 |
| Participant 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 |
| Participant exclusion criteria | 1. Severe physical/mental illness 2. Significant learning difficulties 3. Unable to give informed consent. |
| Recruitment start date | 01/08/2022 |
| Recruitment end date | 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 | 31/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| 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
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.
