Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/02/2007
Date assigned
27/04/2007
Last edited
04/07/2007
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 Susan Smith

ORCID ID

Contact details

Department of Public Health and Primary Care
Trinity Centre for Health Sciences
AMiNCH
Tallaght
Dublin 24
-
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RP/2005/178

Study information

Scientific title

Acronym

Study hypothesis

To examine the effects of a psychological, family-based intervention to improve biophysical, psychosocial and behavioural outcomes for patients with poorly controlled type 2 diabetes.

Ethics approval

The Joint Research Ethics Committee of St. James's Hospital and the Federated Dublin Voluntary Hospitals, approved on the 8th February 2006.

Study design

This study is a randomised controlled trial with an intervention group and a control group.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Type 2 diabetes

Intervention

The study is a psychological intervention, designed to change peoples’ cognitions about their diabetes, with a view to improving diabetes self-management behaviours, and ultimately diabetes outcomes. The intervention is aimed at changing any negative or misperceptions about diabetes, and improving, in a positive direction, the degree of similarity between patient and family members’ cognitions in relation to diabetes.

The intervention will be delivered by a health psychologist who is trained in using motivational interviewing techniques. The intervention also incorporates a family member of the person with diabetes, and will also focus on the family members’ cognitions about diabetes. The participants in the control group receive the usual care.

The intervention will be delivered over three sessions, one session a week. Participants will be followed up at 6 months from time of randomisation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary outcomes will be collected at baseline and at 6-month follow up.
1. HbA1c
2. Illness perceptions
3. Psychological well-being

Secondary outcome measures

Secondary measures will be collected at baseline and at 6-month follow up.
1. Biomedical outcomes
a. Blood pressure
b. Body mass index
c. Cholesterol
2. Diabetes self-efficacy
3. Social support
4. Daily activities
5. Self-care activities

Overall trial start date

01/04/2006

Overall trial end date

30/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Have type 2 diabetes for more than one year, and at least two out of their last three HbA1c readings have been 8.0% or over, in order to identify patients with persistent poor control
2. Over 18 years of age
3. Have fluency in English

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

122

Participant exclusion criteria

Patients with a significant mental or physical illness, as determined by the patients’ clinician, will be excluded. “Significant mental or physical illness “is defined as any illness that is thought likely to impair the patient’s capacity to change their lifestyle behaviour or assimilate new information.

Recruitment start date

01/04/2006

Recruitment end date

30/03/2009

Locations

Countries of recruitment

Ireland

Trial participating centre

Department of Public Health and Primary Care
Dublin 24
-
Ireland

Sponsor information

Organisation

Health Research Board (Ireland)

Sponsor details

73 Lower Baggot Street
Dublin 2
-
Ireland

Sponsor type

Government

Website

http://www.hrb.ie/

Funders

Funder type

Government

Funder name

Health Research Board, Research Project Grant - General 2005 (RP/2005/178) (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Study protocol: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17597523

Publication citations

  1. Study protocol

    Keogh KM, White P, Smith SM, McGilloway S, O'Dowd T, Gibney J, Changing illness perceptions in patients with poorly controlled type 2 diabetes, a randomised controlled trial of a family-based intervention: protocol and pilot study., BMC Fam Pract, 2007, 8, 36, doi: 10.1186/1471-2296-8-36.

Additional files

Editorial Notes