Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)

• Sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim (Other)
• Overall Status: Completed
• CT.gov ID: NCT01220557
• Collaborator: (none)
• Enrollment: 160
• Arms: 2
• Duration (Months): 18

Study Details

Study Description

Brief Summary

This study is a randomized prospective trial with 6-month follow up. A non-inferiority hypothesis is tested. A new developed treatment and education programme for type 1 diabetic patients (PRIMAS) will be tested compared to an established treatment and education programme (German DTTP). Primary outcome variable is glycemic control at 6-month follow up. Secondary outcome variables are: diabetes knowledge, diabetes related distress, depressive symptoms, diabetes self-efficacy, self-care behavior, attitudes towards diabetes and insulin treatment, hypoglycemia awareness.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Behavioral: PRIMAS; Behavioral: DTTP	N/A

Detailed Description

Both programmes consists of 12 lessons with a length of 90 minutes. Eligible type 1 diabetic patients in a diabetologist practice are pooled and randomised either to the new developed PRIMAS programme or to an established education programme for type 1 diabetic patients (DTTP

• Treatment and education programme for intensified insulin treatment) as an active comparator.

Study Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Trial for the Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRIMAS group PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material	Behavioral: PRIMAS; PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
Active Comparator: Control group The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.	Behavioral: DTTP; The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.; Other Names: The German Diabetes Teaching and Treatment Programme ZI Treatment and Education Program for intensified insulin theapy

Outcome Measures

Primary Outcome Measures

1. Changes in Glycemic Control Measured by A1c [Baseline and 6 months]

   Difference between baseline A1c and A1c at 6 month follow up. Equivalent effect on glycemic control measured by A1c (non-inferiority). In case of-non-inferiority test of superiority.

Secondary Outcome Measures

1. Diabetes Knowledge [6 month]

   To assess knowledge among insulin-treated diabetes patients, participants completed a new developed 11-item diabetes knowledge score. Each item had to be answered by selecting the correct answer from multiple choices. The numbers of correct answers are summed up; thus, the range of the diabetes knowledge score is between 0 and 11.

2. Hypoglycaemia Awareness Score [6 month]

   The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.

3. Diabetes Empowerment Score (DES) [6 month follow up]

   Empowerment was measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.

4. Summary of Diabetes Self-Care Activities (SDSCA) [6 month]

   The Summary of Diabetes Self-Care Activities (SDSCA) measure is a self-report measure of diabetes self-management assessing several aspects of the diabetes regimen.

5. Diabetes Distress Scale (DDS) [6 month follow up]

   Diabetes related distress was assessed by a German version of the Diabetes Distress Scale (DDS). The DDS is a 17-item self-report scale for the assessment of emotional burdens in diabetes treatment in both type 1 and type 2 diabetes.

6. CES-D Score [6 month follow up]

   Depressive symptoms were assessed using the German version of the Centre for Epidemiologic Studies Depression Scale (CES-D), an instrument for measuring number and severity of depressive symptoms.

7. Diabetes Self-Efficacy Scale [6 Month Follow up]

   A German version of the Diabetes Self-efficacy Scale was used to assess diabetes specific self-efficacy.

8. Treatment Satisfaction / Problem Areas in Dealing With Diabetes [6 Month Follow up]

   Satisfaction with current diabetes treatment was assessed by a diabetes satisfaction questionnaire developed by Kulzer et al. This questionnaire uncovers problems in dealing with diabetes, also. A high score indicates dissatisfaction with insulin therapy.

9. Evaluation of the Diabetes Education Course [6 month Follow up]

   Patients satisfaction with the diabetes education programs was assessed using a self-constructed 12-item scale on specific questions regarding contents and performance of the training. Response mode was a scale ranging from 4 (apply very strong) to 0 (apply not at all). Additionally, patients were asked to give an overall grade for their course ranging from 1 (very good) to 6 (unsatisfactory).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

type 1 diabetes, diabetes duration > 4 weeks, age 18 - 75 years, BMI 20 - 40 kg/m², A1c 7 - 13 %, ability to understand, speak and write German language, written informed consent.

Exclusion criteria:

current treatment of psychological or psychiatric disorder, dementia or severe cognitive impairment, severe organic disease (e.g. terminal renal disease, cancer with poor prognosis), preventing a regular participation in the training course, pregnancy.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Forschungsinstitut der Diabetes Akademie Mergentheim

Investigators

• Principal Investigator: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim
• ClinicalTrials.gov Identifier: NCT01220557
• Other Study ID Numbers: NH062010
• First Posted: Oct 14, 2010
• Last Update Posted: Aug 17, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim: Diabetes mellitus, education, self management
• Additional relevant MeSH terms: Diabetes Mellitus, Type 1; Insulin

Study Results

Participant Flow

Recruitment Details	The participants were recruited in 23 outpatient study centres, which were located all over Germany. A study centre was defined as a medical practice run by a diabetologist and a diabetes educator or diabetes nurse.

Arm/Group Title	PRIMAS Group	Control Group
Arm/Group Description	PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material	The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
Period Title: Overall Study
STARTED	81	79
COMPLETED	75	74
NOT COMPLETED	6	5

Baseline Characteristics

Arm/Group Title	PRIMAS Group	Control Group	Total
Arm/Group Description	PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material	The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.	Total of all reporting groups
Overall Participants	81	79	160
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	74 91.4%	77 97.5%	151 94.4%
>=65 years	7 8.6%	2 2.5%	9 5.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.9 (13.8)	45.1 (13.4)	45.5 (13.5)
Sex: Female, Male (Count of Participants)
Female	31 38.3%	39 49.4%	70 43.8%
Male	50 61.7%	40 50.6%	90 56.3%
Region of Enrollment (participants) [Number]
Germany	81 100%	79 100%	160 100%

Outcome Measures

1. Primary Outcome

Title	Changes in Glycemic Control Measured by A1c
Description	Difference between baseline A1c and A1c at 6 month follow up. Equivalent effect on glycemic control measured by A1c (non-inferiority). In case of-non-inferiority test of superiority.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRIMAS Group	Control Group
Arm/Group Description	PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material	The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
Measure Participants	75	74
Mean (Standard Deviation) [Changes in A1c in percentage points]	-0.4 (1.0)	0.0 (0.6)

2. Secondary Outcome

Title	Diabetes Knowledge
Description	To assess knowledge among insulin-treated diabetes patients, participants completed a new developed 11-item diabetes knowledge score. Each item had to be answered by selecting the correct answer from multiple choices. The numbers of correct answers are summed up; thus, the range of the diabetes knowledge score is between 0 and 11.
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Hypoglycaemia Awareness Score
Description	The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Diabetes Empowerment Score (DES)
Description	Empowerment was measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
Time Frame	6 month follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Summary of Diabetes Self-Care Activities (SDSCA)
Description	The Summary of Diabetes Self-Care Activities (SDSCA) measure is a self-report measure of diabetes self-management assessing several aspects of the diabetes regimen.
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Diabetes Distress Scale (DDS)
Description	Diabetes related distress was assessed by a German version of the Diabetes Distress Scale (DDS). The DDS is a 17-item self-report scale for the assessment of emotional burdens in diabetes treatment in both type 1 and type 2 diabetes.
Time Frame	6 month follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	CES-D Score
Description	Depressive symptoms were assessed using the German version of the Centre for Epidemiologic Studies Depression Scale (CES-D), an instrument for measuring number and severity of depressive symptoms.
Time Frame	6 month follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Diabetes Self-Efficacy Scale
Description	A German version of the Diabetes Self-efficacy Scale was used to assess diabetes specific self-efficacy.
Time Frame	6 Month Follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Treatment Satisfaction / Problem Areas in Dealing With Diabetes
Description	Satisfaction with current diabetes treatment was assessed by a diabetes satisfaction questionnaire developed by Kulzer et al. This questionnaire uncovers problems in dealing with diabetes, also. A high score indicates dissatisfaction with insulin therapy.
Time Frame	6 Month Follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Evaluation of the Diabetes Education Course
Description	Patients satisfaction with the diabetes education programs was assessed using a self-constructed 12-item scale on specific questions regarding contents and performance of the training. Response mode was a scale ranging from 4 (apply very strong) to 0 (apply not at all). Additionally, patients were asked to give an overall grade for their course ranging from 1 (very good) to 6 (unsatisfactory).
Time Frame	6 month Follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	6 months
Arm/Group Title	PRIMAS Group		Control Group
Arm/Group Description	PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material PRIMAS: PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material		The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material. DTTP: The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
All Cause Mortality
	PRIMAS Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	PRIMAS Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/81 (0%)		0/79 (0%)
Other (Not Including Serious) Adverse Events
	PRIMAS Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/81 (0%)		0/79 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.