Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/12/2014
Date assigned
18/02/2015
Last edited
18/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
In children and adolescents type 1 diabetes is the most predominant form of diabetes in Sweden. Diabetes is a condition that causes a person’s blood sugar (glucose) level to become too high. Insulin is a hormone (produced by an organ called the pancreas) that controls the amount of glucose in the blood. Type 1 diabetes occurs when the pancreas does not make any insulin. People with type 1 diabetes have to give themselves insulin every day. The most common way to do this is by injections, but insulin pump is an alternative. Regardless of treatment, less than half of Swedish diabetic paediatric patients (patients under 18) are able to bring down the amount of glucose in their blood back down to normal levels. There are clear, age-related differences in blood glucose control. After the diabetic child starts school at 7 years of age, the blood glucose levels tend to increase, and continues to increase more as the child gets older. Teenage girls tend to have the worse glucose control of all age groups. Adolescent patients with diabetes should be able to take more responsibility for management of their own diabetes and not rely on their parents to manage their condition for them. However, how this responsibility is shared in this transition period is often unclear. There is much published support for continued parental involvement and shared responsibility for managing the child’s diabetes during adolescence. The relationship between parent and child appears to be important in managing the child’s glucose levels. Adolescents who have many diabetes-related conflicts with their parents have higher glucose levels compared with those who have fewer conflicts. Teenagers describe how parental involvement can be helpful or damaging. Person-centred care focuses on seeing a person as an individual rather than simply concentrating on their illness and helps to engage the person as an active partner in his/her own care and treatment. When a child or an adolescent has diabetes the whole family needs to be involved and the parents are often the primary caregivers. Guided self-determination-Young (GSD-Y) is a person-centred reflection model that intends to guide the teenager, while working with their parents and health care professionals to develop the skills necessary to manage difficulties in diabetes self-management by using a structured worksheet. It has proved successful in improving the life skills in teenagers in a Danish study. We want to test whether an intervention (treatment) with Guided Self Determination Young (GSD-Y), in female adolescents and their parents, leads to improved blood glucose control, self-management, treatment satisfaction, perceived health and quality of life, fewer diabetes-related family conflicts and improved psychosocial self-efficacy (their own belief in managing the effects of living with diabetes). The reason we have chosen female adolescents is that they have more difficulty in controlling their blood glucose levels than males.

Who can participate?
Female diabetics aged between 15-20 and their parents. All participants must not have any problems understanding Swedish.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (control) are given their standard care and visit a diabetes nurse or physician every two to three months. Those in group 2 (treatment) are given standard care and also receive seven individual GSD-Y education visits of between an hour and 90 minutes in length. These visits are with a diabetes nurse, dietician or a physician and occur over six to eight month period.

What are the possible benefits and risks of participating?
Participants in the treatment group will receive an education that hopefully leads to improved glucose control, self-management, treatment satisfaction and quality of life, fewer diabetes-related family conflicts and improved psychosocial self-efficacy. The study is not associated with any known increased risks. However, it is possible that patients participating in the study feel that they are more reminded of their illness.

Where is the study run from?
Sachs´ Children and Youths Hospital, Söderjukhuset, Stockholm (Sweden)

When is study starting and how long is it expected to run for?
January 2015 to December 2019

Who is funding the study?
1. Södersjukhuset and Karolinska Institute (Sweden)
2. Diabetes foundation (Sweden)
3. Child Diabetes foundation (Sweden)

Who is the main contact?
1. Anna Lindholm Olinder
anna.lindholm-olinder@sodersjukhuset.se
2. Josephine Haas
josephine.haas@sodersjukhuset.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna Lindholm Olinder

ORCID ID

Contact details

Sachs Children and Youths hospital
Södersjukhuset
Stockholm
118 83
Sweden
0046704846354
anna.lindholm-olinder@sodersjukhuset.se

Type

Scientific

Additional contact

Dr Josephine Haas

ORCID ID

Contact details

Sachs' Children and Youths hospital
Södersjukhuset
Stockholm
118 83
Sweden
004686164000
josephine.haas@sodersjukhuset.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomized controlled trial of an empowerment intervention with guided self-determination- Young for female adolescents with diabetes, evaluating glycemic control and perceived health and quality of life, compared with usual care.

Acronym

GSD-Y females

Study hypothesis

An intervention with guided self-determination-Young may decrease negative impact of diabetes, improve glycemic control and perceived health and quality of life among young females with diabetes.

Ethics approval

Ethical review board in Stockholm, 03/12/2014, ref: 2014/1942-31-2

Study design

Open randomized controlled intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in English

Condition

Diabetes

Intervention

In addition to standard care the intervention group will receive seven individual Guided Self-Determination-Young (GSD-Y) education visits (1-1.5 h) with a diabetes nurse, dietician or a physician over six to eight months. The facilitator has got specific education during 40 hours regarding the current method. The GSD-Y method implies that the participant works with structured reflection sheets. Prior to each visit the participant is supposed to have filled in a reflection sheet. By filling in the reflection sheet using their own words and drawings, adolescents and their parents systematically explore and express their own experiences and difficulties with diabetes in daily life. In the dialogue, between the participant and the facilitator, the facilitator uses different communication models, including mirroring, active listening and value-clarifying responses. The control group will receive standard care, and are called for visits to the diabetes nurse or the physician on the unit, every second to third month.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Glycemic control, measured with HbA1c

Outcome will be measured at baseline and after 6, 12 and 24 months

Secondary outcome measures

1. Self-management: mean frequency of self-monitoring of blood glucose (SMBG)
2. Treatment satisfaction: DTSQ Teen and Parent
3. Perceived health and quality of life: Check your health,
4. Diabetes-related family conflicts: Diabetes Family Conflict Scale (DFCS)
5. Psychosocial self-efficacy: Swedish Diabetes Empowerment Scale (Swe-DES 23)

All outcomes will be measured at baseline and after 6, 12 and 24 months

Overall trial start date

01/01/2015

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Female adolescents with diabetes

Participant type

Patient

Age group

Child

Gender

Female

Target number of participants

100

Participant exclusion criteria

Difficulties understanding Swedish

Recruitment start date

15/09/2015

Recruitment end date

01/09/2019

Locations

Countries of recruitment

Sweden

Trial participating centre

Sachs' children and youths hospital
Södersjukhuset
Stockholm
118 83
Sweden

Sponsor information

Organisation

Karolinska Institute / Södersjukhuset

Sponsor details

Sachs' children and youths hospital
Södersjukhuset
Stockholm
118 83
Sweden

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Children Diabetes Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Diabetes foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish a study protocol in BMC pediatrics during spring 2015. The results will be published in scientific journals and presented at different conferences.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes