Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/09/2013
Date assigned
17/03/2014
Last edited
17/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
NHS Highland is the largest Health Board in the UK geographically speaking. It covers an area of over 300,000km2 including many outlying Scottish islands and some of the remotest parts of the British mainland. Within this area there are around 14,000 patients with diabetes, of which around 1,500 have a diagnosis of type 1 diabetes. Access to specialist clinical services are limited to central clinics in Inverness and outreach clinics in Skye, Fort William and Wick. Follow up between these clinic appointments is delivered by community based Diabetes Specialist Nurses. At present, these contacts are conducted by traditional face-to-face clinic visits then, perhaps, telephone visits if required in between. This type of interaction invariably requires patients and staff to travel potentially great distances, often on poor roads or during inclement weather conditions. It is also worth noting that type 1 diabetes is a disease predominantly of the young and certainly of those of working age, or those engaged in education. The requirement for clinical consultation to be face-to-face currently requires the patient to take time off work or out of education.
This study will investigate the usability and acceptability of digital communication methods to patients with indifferent control of their type 1 diabetes. The type of clinic that is proposed will enable the same functionality of a 'traditional' diabetes clinic, but it will not require patients or staff to meet face-to-face. Patients views on the digital means of communication will be captured with questionnaires. Phase 1 and 2 will develop a technology acceptance questionnaire to be used in the main study (phase 3). Digital means of communication will be video consultation, email, text and phone. All treatment offered, or blood samples taken, will be in accordance with standard clinical practice for patients with indifferent control of their diabetes.

Who can participate?
Adults who have had a diagnosis of type 1 diabetes for more than 12 months. Participants must have access to the internet, a PC or laptop with a webcam, an email address and a mobile phone and be able to give informed consent.


What does the study involve?
Patients meeting the criteria will be identified by members of the Diabetes Specialist Service within NHS Highland. These patients will either be approached at clinic or invited by letter to participate in the study. They will be given a copy of the Patient Information Sheet to read and consider. A period of at least 24 hours will be allowed for this.
Phase 1 & 2: participants will only complete a questionnaire.
Phase 3: participants will then be invited to attend a meeting with the research practitioner in person to discuss the study in more detail before being consented for it. After giving consent, the participant will complete 3 questionnaires and will be shown how to use WebEx software (videoconsultation platform which has been approved for NHS use by NHS Highland eHealth Dept.). Text number, phone number and email address of the research practitioner will be given to the participant. A mutually agreeable date will be set for the 1st virtual clinic consultation using WebEx. Further dates will be set up at 3 and 6 months, again at mutually agreeable times. Prior to the 1st meeting, the participant will be required to have an HbA1c blood test completed by their GP if their last test was more than 6 weeks before the clinic appointment. The participants will be required to have HbA1c blood tests completed at 3 and 6 months, again prior to the WebEx consultation. Between the video consultations the patients will be invited to communicate with the research practitioner via text, email or phone for treatment advice and help to optimise treatment. Participants' self- monitoring of blood glucose results will be shared between the participant and the research practitioner via WebEx 'share' function (where one person on the call shares their computer screen or document on their computer with another person). After the final clinic visit, the participant will be contacted by a research fellow and asked to complete 3 questionnaires.

What are the possible benefits and risks of participating?
Participation will help our researchers to advance understanding of the acceptability of digital methods of communication for running a diabetes clinic. There are no anticipated risks.

Where is the study run from?
The study is being run within the Highland Clinical Research Facility, Inverness (UK).

When is study starting and how long is it expected to run for?
Phase 1 and 2 of the study will be open from October 2013 and Phase 3 of the study will start in March 2014. Recruitment will be open for up to 1 year. Each participant recruited will be in the study for 6 months.

Who is funding the study?
The Scottish Diabetes Group (UK).

Who is the main contact?
Gordon Rushworth, Lead Pharmacist Diabetes, +44 (0)1463 279586

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sandra MacRury

ORCID ID

Contact details

Highland Clinical Research Facility
Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

409SM

Study information

Scientific title

A pilot study to test the usability and acceptability of virtual support for patients with type 1 diabetes in Highland region

Acronym

DDP

Study hypothesis

To determine the usability and acceptability of a variety of digital communication modes between the specialist diabetes team and patients with diabetes.

Ethics approval

NRES Committee London-Bloomsbury, REC Reference: 13/LO/1232

Study design

Mixed Methods Study

Primary study design

Observational

Secondary study design

Other

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetes

Intervention

The type of clinic that is proposed will enable the same functionality of a traditional diabetes clinic, but it will not require patients or staff to meet face-to-face. Phase 1 and 2 will develop a technology acceptance questionnaire to be used in the main study (phase 3). Digital means of communication will be video-consultation, email, text and phone. All treatment offered, or blood samples taken, will be in accordance with standard clinical practice for patients with indifferent control of their diabetes. Patients views on the digital means of communication will be captured with questionnaires.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To determine the usability and acceptability of a variety of digital communication modes between the specialist diabetes team and patients with diabetes.

An elicitation questionnaire exploring patients' views on a digital diabetes clinic will be used in phase 1 of the study to develop an evaluation questionnaire to be piloted in phase 2 of the study. The method to be used to measure the outcomes for the main part of the study (phase 3) will be 3 questionnaires. There will be a self-efficacy for diabetes questionnaire, summary of diabetes self-care activities questionnaire and the evaluation questionnaire which has been validated in phase 1 and 2.

Secondary outcome measures

To determine if secure, reliable methods can be established for sharing blood glucose data and for assimilating different modes of communication into patient records in addition to assessment of change in glycaemia control.

Overall trial start date

01/10/2013

Overall trial end date

01/10/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Type 1 diabetes
2. Over 18
3. Glycosylated hemoglobin (HbA1c) > 64mmol/mol (8%)
4. Diabetes duration of more than 12 months
5. Access to the internet
6. Ability to give informed consent
7. Access to a personal computer (PC) or laptop with a webcam
8. Have an email address
9. Have a mobile phone

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Phase 1 & 2 = 25, phase 3 = 20.

Participant exclusion criteria

1. Any form of diabetes other than type 1
2. Those on insulin pump therapy
3. HbA1c ≤ 64mmol/mol (≤8%)
4. Diabetes duration of less than 12 months
5. Those without access to a PC or laptop which includes a webcam
6. Those without internet access
7. Those without an email address
8. Those without a mobile phone
9. Unable to use a PC, mobile phone or email

Recruitment start date

01/10/2013

Recruitment end date

01/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Highland Clinical Research Facility
Inverness
IV2 3JH
United Kingdom

Sponsor information

Organisation

University of the Highlands and Islands (UK)

Sponsor details

c/o Jeff Howarth
VP Research and Enterprise
UHI Executive Office
Ness Walk
Inverness
IV3 5SQ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Scottish Diabetes Group (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes