A randomized controlled trial of an empowerment intervention for female adolescents with diabetes.

• Register: ISRCTN
• Last refreshed on: 4 December 2023
• Main ID: ISRCTN57528404
• Date of registration: 18/02/2015
• Prospective Registration: Yes
• Primary sponsor: Karolinska Institute / Södersjukhuset
• Public title: A randomized controlled trial of an empowerment intervention for female adolescents with diabetes.
• Scientific title: A randomized controlled trial and a qualitative interview study of an empowerment intervention (Guided Self-Determination - Young) for female adolescents with diabetes, evaluating glycemic control and perceived health and quality of life, compared with usual care
• Date of first enrolment: 01/05/2017
• Target sample size: 100
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN57528404
• Study type: Interventional
• Study design: A mixed methods study including an open randomized controlled intervention study and a qualitative interview study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Anna Lindholm Olinder

Key inclusion & exclusion criteria

Inclusion criteria: Female adolescents with diabetes
Exclusion criteria: Difficulties understanding Swedish

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Diabetes
Nutritional, Metabolic, Endocrine
Type 1 diabetes

Intervention(s)

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.

Primary Outcome(s)

Current primary outcome measure as of 04/01/2022:
Glycemic control assessed using HbA1c measured at baseline and after 6 and 12 months
_____

Previous primary outcome measure:
Glycemic control, measured with HbA1c

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

Secondary Outcome(s)

Current secondary outcome measures as of 04/01/2022:
1. Self-management assessed using mean frequency of self-monitoring of blood glucose (SMBG)
2. Treatment satisfaction assessed using DTSQ Teen and Parent
3. Perceived health and quality of life assessed using Check your health
4. Diabetes-related family conflicts assessed using Diabetes Family Conflict Scale (DFCS)
5. Psychosocial self-efficacy assessed using Swedish Diabetes Empowerment Scale (Swe-DES 23)

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

Previous 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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Children Diabetes Foundation (Sweden), Diabetes foundation (Sweden)

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Ethical review board in Stockholm, 03/12/2014, ref: 2014/1942-31-2

Results

• Results available: Yes
• Date Completed: 31/12/2022