EMPOWER - Support of Patient Empowerment by an intelligent self-management pathway for patients

EMPOWER - Support of Patient Empowerment by an intelligent self-management pathway for patients - EMPOWER

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007699

Enrollment

140

Registered

2015-01-30

Start date

2014-08-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10 E11

Interventions

Group 1: In the test-phase of EMPOWER, patients will be assigned to an intervention group and a control group. In accordance with the treating physician the intervention group will use the online EMPO

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Eligible participants are between 18 and 65 years of age and suffer from diabetes type 1 or 2. Moreover, they need to have access to internet, own a computer or smart phone and be able to use the EMPOWER application.

Exclusion criteria

Exclusion criteria: Patients who: - do not suffer from diabetes - are younger than 18 years - who have no internet access.

Design outcomes

Primary

Measure	Time frame
The pre-questionnaire will only contain questions on self-management related constructs and socio-demographics, the post-questionnaire will also measure the perceived usability and usefulness of the application. Both questionnaires will be administered online and take about 20 to 30 minutes. Pre-post-comparisons will be facilitated by the random and thus anonymous assignment of a unique code for each participant that has to be entered when starting the survey. Patient Information Basic recordings about the patients comprise information such as socio-demographic descriptions, number of physician consultations during the intervention phase, or his/her experience with using similar technologies. Besides, the usage of EMPOWER will be recorded for each participant, including a patient’s number of logins to the system, the duration of use per visit, or the number of goals entered into the system. The records will show how often and intense the system was actually used by participants, and allow conclusions about the most useful features of the tool. Subjectively reported information from the patients will then be compared to objectively collected data. Usability Usability will be measured using the System Usability Scale. The scale was developed to assess the usability of interactive systems and is commonly used for this purpose. It consists of ten items that ask for a subjective assessment of the system, e.g. how easy it was to use it or how well integrated the various features of the system are. Both, reliability and validity of the scale have been proven. Questions to assess the perceived usefulness of the EMPOWER system are based on the Technology Acceptance Model. The model considers why technological systems are accepted or rejected by its users and how certain characteristics of the system determine this process. To measure the perceived usefulness of the EMPOWER system ten items from Davis’ short screening scale on technology acceptance are used and were slight	—

Measure

Time frame

The pre-questionnaire will only contain questions on self-management related constructs and socio-demographics, the post-questionnaire will also measure the perceived usability and usefulness of the application. Both questionnaires will be administered online and take about 20 to 30 minutes. Pre-post-comparisons will be facilitated by the random and thus anonymous assignment of a unique code for each participant that has to be entered when starting the survey. Patient Information Basic recordings about the patients comprise information such as socio-demographic descriptions, number of physician consultations during the intervention phase, or his/her experience with using similar technologies. Besides, the usage of EMPOWER will be recorded for each participant, including a patient’s number of logins to the system, the duration of use per visit, or the number of goals entered into the system. The records will show how often and intense the system was actually used by participants, and allow conclusions about the most useful features of the tool. Subjectively reported information from the patients will then be compared to objectively collected data. Usability Usability will be measured using the System Usability Scale. The scale was developed to assess the usability of interactive systems and is commonly used for this purpose. It consists of ten items that ask for a subjective assessment of the system, e.g. how easy it was to use it or how well integrated the various features of the system are. Both, reliability and validity of the scale have been proven. Questions to assess the perceived usefulness of the EMPOWER system are based on the Technology Acceptance Model. The model considers why technological systems are accepted or rejected by its users and how certain characteristics of the system determine this process. To measure the perceived usefulness of the EMPOWER system ten items from Davis’ short screening scale on technology acceptance are used and were slight

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Secondary

Measure	Time frame
Empowerment Patients’ empowerment will be measured using Spreitzer’s Empowerment Scale (1995) and The Problem Areas in Diabetes (PAID) Welche et al., 1997). Spreitzer’s Empowerment Scale consists of twelve statements related to the patient’s perceived importance, control, management, and autonomy concerning his/her diabetes. The PAID asks the patient whether he/she perceives twenty aspects, such as being limited concerning nutrition or not having treatment goals, as current problems. Self-Management Activities The impact of patient empowerment on self-management activities through the use of the EMPOWER system will be assessed by measuring the patients’ pre- and post-intervention health status, diabetes self-care, health literacy, doctor-patient communication, and empowerment. To assess an overall effect of the application on the health status as perceived by the patient, a self-reported, one item measure will be used. Patients will be asked to rate their health independently from their diabetes to avoid negatively biased answers due to the chronic condition. Diabetes self-care will also be measured subjectively, using the SDSCA (Summary of Diabetes Self-Care Activities Measure). The scale focuses on the patients’ self-care across various dimensions such as diet, exercise, blood sugar testing, foot care, and smoking. The questions refer to the last seven days of a participant’s routine diabetes self-care and therefore represent a comprehensive insight into the patient’s self-management that will be completed by the objective data stemming from the user tracking. Health Literacy As an adequate level of heath literacy is paramount for being an effective self-manager possible changes in health literacy due to the use of the EMPOWER system are assessed. Therefore, the Newest Vital Sign (NVS), an objective test of functional health literacy in form of a nutrition label will be employed. Further, a subjective measure consisting of three items related to the perceived	—

Measure

Time frame

Empowerment Patients’ empowerment will be measured using Spreitzer’s Empowerment Scale (1995) and The Problem Areas in Diabetes (PAID) Welche et al., 1997). Spreitzer’s Empowerment Scale consists of twelve statements related to the patient’s perceived importance, control, management, and autonomy concerning his/her diabetes. The PAID asks the patient whether he/she perceives twenty aspects, such as being limited concerning nutrition or not having treatment goals, as current problems. Self-Management Activities The impact of patient empowerment on self-management activities through the use of the EMPOWER system will be assessed by measuring the patients’ pre- and post-intervention health status, diabetes self-care, health literacy, doctor-patient communication, and empowerment. To assess an overall effect of the application on the health status as perceived by the patient, a self-reported, one item measure will be used. Patients will be asked to rate their health independently from their diabetes to avoid negatively biased answers due to the chronic condition. Diabetes self-care will also be measured subjectively, using the SDSCA (Summary of Diabetes Self-Care Activities Measure). The scale focuses on the patients’ self-care across various dimensions such as diet, exercise, blood sugar testing, foot care, and smoking. The questions refer to the last seven days of a participant’s routine diabetes self-care and therefore represent a comprehensive insight into the patient’s self-management that will be completed by the objective data stemming from the user tracking. Health Literacy As an adequate level of heath literacy is paramount for being an effective self-manager possible changes in health literacy due to the use of the EMPOWER system are assessed. Therefore, the Newest Vital Sign (NVS), an objective test of functional health literacy in form of a nutrition label will be employed. Further, a subjective measure consisting of three items related to the perceived

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Countries

Germany, Turkey

Contacts

Public ContactSiegfried Jedamzik

Gesundheitsorganisation GOIN

siegfried.jedamzik@go-in-ingolstadt.de0049 841 956161

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 5, 2026