A randomised controlled trial to determine whether family centred structured education improves blood glucose control in adolescents with type 1 diabetes
| ISRCTN | ISRCTN89756583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89756583 |
| Protocol serial number | Version 1.0 23 April 2007 |
| Sponsor | The Ipswich Hospital NHS Trust (UK) |
| Funder | Diabetes UK |
- Submission date
- 26/11/2007
- Registration date
- 10/03/2008
- Last edited
- 19/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helen Murphy
Scientific
Scientific
Diabetes Centre
Heath Road
Ipswich
IP4 5PD
United Kingdom
| Phone | +44 1473 704759 |
|---|---|
| helen.murphy@ipswichhospital.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | FACTS 2 - Family's and Adolescent's Communication and Teamwork Study |
| Study objectives | 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 |
| Ethics approval(s) | Approved by the Suffolk Research Ethics Committee (REC) on 15 August 2007 (ref: 07/H0307/67) |
| Health condition(s) or problem(s) studied | Type 1 diabetes |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
Glycaemic control (HbA1c) at 12 months follow-up |
| Key secondary outcome measure(s) |
1. Frequency of hypoglycaemia. Duration of follow-up: 12 months |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | Adolescents with type 1 diabetes aged 11-16 years old |
| Key exclusion criteria | Serious medical or psychological co-morbidity which would limit ability to participate in the group education sessions. |
| Date of first enrolment | 24/10/2007 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Diabetes Centre
Ipswich
IP4 5PD
United Kingdom
IP4 5PD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | Yes | No |
