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
Secondary identifying numbers	Version 1.0 23 April 2007

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

Not provided at time of registration

Contact information

Dr Helen Murphy
Scientific

Diabetes Centre
Heath Road
Ipswich
IP4 5PD
United Kingdom

Phone	+44 1473 704759
Email	helen.murphy@ipswichhospital.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Scientific title
Study acronym	FACTS 2 - Family's and Adolescent's Communication and Teamwork Study
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
Ethics approval(s)	Approved by the Suffolk Research Ethics Committee (REC) on 15 August 2007 (ref: 07/H0307/67)
Condition	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	Glycaemic control (HbA1c) at 12 months follow-up
Secondary outcome measures	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
Overall study start date	24/10/2007
Overall study end date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	11 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	300
Participant inclusion criteria	Adolescents with type 1 diabetes aged 11-16 years old
Participant exclusion criteria	Serious medical or psychological co-morbidity which would limit ability to participate in the group education sessions.
Recruitment start date	24/10/2007
Recruitment end date	01/09/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Diabetes Centre

Ipswich
IP4 5PD
United Kingdom

Sponsor information

The Ipswich Hospital NHS Trust (UK)
Hospital/treatment centre

Heath Road
Ipswich
IP4 5PD
England
United Kingdom

Phone	+44 1473 704343
Email	research.office@ipswichhospital.nhs.uk
Website	http://www.ipswichhospital.org.uk/

Funders

Funder type

Charity

Diabetes UK
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): DIABETES UK LIMITED, British Diabetic Association
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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