| Source of record | UK Trials |
| ISRCTN | ISRCTN89756583 |
| Date ISRCTN assigned | 10/03/2008 |
| Local reference number(s) | Version 1.0 23 April 2007 |
| Public title | A randomised controlled trial to determine whether family centred structured education improves blood glucose control in adolescents with type 1 diabetes |
| Scientific title |
|
| Acronym | FACTS 2 - Family's and Adolescent's Communication and Teamwork Study |
| Disease/condition/study domain | Type 1 diabetes |
| Study hypothesis | Does structured education with family communication training help adolescents with type 1 diabetes to improve blood glucose control?
FACTS 1 study results in http://www.ncbi.nlm.nih.gov/pubmed/17894831 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Approved by the Suffolk Research Ethics Committee (REC) on 15 August 2007 (ref: 07/H0307/67) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Adolescents with type 1 diabetes aged 11-16 years old |
| Participants - exclusion criteria | Serious medical or psychological co-morbidity which would limit ability to participate in the group education sessions. |
| Patient information material |
|
| Anticipated start date | 24/10/2007 |
| Anticipated end date | 01/09/2010 |
| Status of trial | Ongoing |
| Target number of participants | 300 |
| Interventions | Family centred structured education programme (intervention) vs standard outpatient care (control)
The key activities of the programme are:
6 x 90 min small group sessions at monthly intervals over 6 months with parents and adolescents seen together. It includes a combination of skills based and family-communication based sessions addressing blood glucose monitoring, food flexibility, insulin dose adjustment, hypoglycaemia, sports, school issues, challenges during adolescence, family communication and conflict resolution. It has a written philosophy and curriculum with a programme for training and quality development of the educators. |
| Primary outcome measure(s) | Glycaemic control (HbA1c) at 12 months follow-up |
| Secondary outcome measure(s) | 1. Frequency of hypoglycaemia. Duration of follow-up: 12 months
2. Quality of Life and Family Responsibility questionnaire measures (Paediatric Quality of Life Inventory [PedsQL], Diabetes Family Responsibility [DFRQ], Problem Areas in Diabetes [PAID]) at 6 months |
| Sources of funding | Diabetes UK |
| Sponsor name | The Ipswich Hospital NHS Trust (UK) |
| Sponsor details | Heath Road
Ipswich
United Kingdom
IP4 5PD |
| Sponsor telephone | +44 1473 704343 |
| Sponsor email | research.office@ipswichhospital.nhs.uk |
| Sponsor website | http://www.ipswichhospital.org.uk/ |
| Contact name | Dr Helen Murphy |
| Contact details | Diabetes Centre
Heath Road
Ipswich
United Kingdom
IP4 5PD |
| Contact telephone | +44 1473 704759 |
| Contact email | helen.murphy@ipswichhospital.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN89756583 |
| Date last extracted from ISRCTN register | 17/04/2008 |
