Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/11/2007
Date assigned
10/03/2008
Last edited
19/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ipswichhospital.org.uk/

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

  1. 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.

Additional files

Editorial Notes