Implementing and evaluating a structured education programme and a new model of ongoing care for type 1 diabetes: the Irish Dose Adjustment For Normal Eating (DAFNE) study

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN79759174
• Date of registration: 09/02/2007
• Primary sponsor: Health Research Board (Ireland)
• Public title: Implementing and evaluating a structured education programme and a new model of ongoing care for type 1 diabetes: the Irish Dose Adjustment For Normal Eating (DAFNE) study DAFNE Ireland
• Scientific title: Implementing and evaluating a structured education programme and a new model of ongoing care for type 1 diabetes: the Irish Dose Adjustment For Normal Eating (DAFNE) study - a randomised controlled trial
• Date of first enrolment: Jan 1 2007
• Target sample size: As of 20/07/10: 438 (previously 360). Added 20/10/2011: Please note that the trial recruited to target (n= 437)
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN79759174
• Study type: Interventional
• Study design: Randomised controlled trial

Countries of recruitment

Ireland

Contacts

• Name: Mary Clare O? Hara

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients diagnosed with type 1 diabetes for over one year
2. Attending the adult diabetes clinic in one of the participating centres
3. Ability to speak and read English
4. Willingness to monitor blood sugar levels at regular intervals
5. Willingness to transition to a basal/bolus insulin regimen prior to DAFNE training (if not already on such a regimen)
6. Glycosylated haemoglobin (HbA1c) level below 13 percent at recruitment

Added as of 13/02/2009:
7. Both males and females, 18 years old or greater

Please note that as of 30/07/07, the previous inclusion criteria point six read as:
6. Glycosylated haemoglobin (HbA1c) level between 7.5 and 13 percent at recruitment
Exclusion criteria: 1. Patients with type 2 diabetes
2. Attending a paediatric clinic
3. Pregnant or planning a pregnancy in the next 2 years
4. Presence of advanced diabetic complications (e.g. kidney failure with serum creatinine >250 µmol/L)
5. Serious co-morbidity likely to interfere with study participation
6. Previous DAFNE training or current use of a continuous subcutaneous insulin infusion pump

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Type 1 diabetes

Intervention(s)

Please note that as of 20/07/10 the end date of this trial has been extended from 31/12/09 to 30/09/2011.

After obtaining informed consent participants will be assigned to the next available DAFNE course in their participating centre. Prior to commencement of the course, baseline data will be collected. If a change to a basal/bolus insulin regimen is required this will be undertaken over the weekend prior to DAFNE training. Participants assigned to usual care will be offered appointments at a diabetes clinic at 6 and 12 months after DAFNE training. These visits will not be structured but efforts will be made to have patients seen by the educator(s) and doctor who participated in their DAFNE training.

Those individuals assigned to the group follow-up arm of the study will receive their follow-up in the original group in which they underwent DAFNE training. Visits will be arranged as close as possible to 6 and 12 months after the course and will be facilitated by one of the group's original 2 DAFNE educators. The curriculum developed in the first phase of the project will be used during these sessions.

An experienced DAFNE educator will combine delivery of a curriculum with a patient-centred approach to priority setting and problem solving. Each group follow-up session will last approximately 2 hours.

Three self-administered questionnaires will be used to measure wellbeing and quality of life. These will be administered at baseline and again at 6, 12 and 18 months after recruitment. Forms will be completed in the diabetes centre as part of a visit to measure study outcomes.

In a subset of participants an in-depth interview will be undertaken to explore the impact that DAFNE training has on the participants' ability to live with and self-manage their diabetes.

In a subset of participants follow-up telephone interviews will be used to establish how the different models of follow-up care being delivered in the study impact on participants' ability to self-manage their diabetes.

Details of Principal Investigator:
Dr Seán Dinneen
Clinical Science Institute
University College Hospital Galway
Newcastle Road, Galway
Ireland
Tel: [phone]
Email: [e-mail]

As of 13/02/2009: Recruitment finished in December 2008. 450 participants have been enrolled to date and are through baseline.

Primary Outcome(s)

Longitudinal change in mean HbA1c level between baseline and follow-up.

Added as of 17/02/2009: All primary and secondary outcomes will be assessed at 6, 12 and 18 months.

Secondary Outcome(s)

1. Rates of severe hypoglycaemia
2. Change in weight and psychological measures of wellbeing and quality of life

Added as of 17/02/2009:
The following scales are used to assess psychological measures of wellbeing and quality of life:
1. Hospital Anxiety and Depression Scale (HADS)
2. Problem Areas in Diabetes (PAID) Questionnaire
3. Disease Specific Quality of Life questionnaire (DSQOL)
4. Euroqol EQ-5D
5. Sub-study: comparison of Audit of Diabetes-Dependent Quality of Life (ADDQOL) vs Diabetes Treatment Satisifaction Questionnaire (DTSQ)
6. Health Economics Questionnaire (developed for the study)

All primary and secondary outcomes will be assessed at 6, 12 and 18 months.

Secondary ID(s)

HS-05-25

Source(s) of Monetary Support

Health Research Board (Ireland) (ref: HS-05-25)

Secondary Sponsor(s)

N/A