Contact information
Type
Scientific
Primary contact
Dr Helen Murphy
ORCID ID
Contact details
Diabetes Centre
Heath Road
Ipswich
IP4 5PD
United Kingdom
+44 1473 704759
helen.murphy@ipswichhospital.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1.0 23 April 2007
Study information
Scientific title
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
Approved by the Suffolk Research Ethics Committee (REC) on 15 August 2007 (ref: 07/H0307/67)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
24/10/2007
Overall trial end date
01/09/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Adolescents with type 1 diabetes aged 11-16 years old
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
300
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
United Kingdom
Trial participating centre
Diabetes Centre
Ipswich
IP4 5PD
United Kingdom
Sponsor information
Organisation
The Ipswich Hospital NHS Trust (UK)
Sponsor details
Heath Road
Ipswich
IP4 5PD
United Kingdom
+44 1473 704343
research.office@ipswichhospital.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Diabetes UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22507080
Publication citations
-
Results
Murphy HR, Wadham C, Hassler-Hurst J, Rayman G, Skinner TC, , Randomized trial of a diabetes self-management education and family teamwork intervention in adolescents with Type 1 diabetes., Diabet. Med., 2012, 29, 8, e249-54, doi: 10.1111/j.1464-5491.2012.03683.x.