Trial Outcomes & Findings for The Effectiveness of Intervention on Insulin Injection (NCT NCT03324451)
NCT ID: NCT03324451
Last Updated: 2020-09-16
Results Overview
Collected from blood test to assess the Glycosylated hemoglobin (HbA1c) levels
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
151 participants
Primary outcome timeframe
At baseline and 12 months after the intervention
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Intervention Arm
The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management
TTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.
|
Control Arm
The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.
Usual care: Regular patient education on insulin injection at the control arm hospital.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
54
|
|
Overall Study
COMPLETED
|
65
|
41
|
|
Overall Study
NOT COMPLETED
|
32
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
some participants were lost
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=97 Participants
The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains three parts: (1) individual intervention; (2) insulin injection follow-up management
TTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.
|
Control Arm
n=54 Participants
The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.
Usual care: Regular patient education on insulin injection at the control arm hospital.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=65 Participants • some participants were lost
|
0 Participants
n=41 Participants • some participants were lost
|
0 Participants
n=106 Participants • some participants were lost
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=65 Participants • some participants were lost
|
25 Participants
n=41 Participants • some participants were lost
|
63 Participants
n=106 Participants • some participants were lost
|
|
Age, Categorical
>=65 years
|
27 Participants
n=65 Participants • some participants were lost
|
16 Participants
n=41 Participants • some participants were lost
|
43 Participants
n=106 Participants • some participants were lost
|
|
Age, Continuous
|
60.91 years
STANDARD_DEVIATION 14.30 • n=65 Participants • some participants were lost follow-up
|
60.02 years
STANDARD_DEVIATION 11.49 • n=41 Participants • some participants were lost follow-up
|
60.57 years
STANDARD_DEVIATION 13.24 • n=106 Participants • some participants were lost follow-up
|
|
Sex: Female, Male
Female
|
30 Participants
n=65 Participants • some participants were lost follow-up
|
23 Participants
n=41 Participants • some participants were lost follow-up
|
53 Participants
n=106 Participants • some participants were lost follow-up
|
|
Sex: Female, Male
Male
|
35 Participants
n=65 Participants • some participants were lost follow-up
|
18 Participants
n=41 Participants • some participants were lost follow-up
|
53 Participants
n=106 Participants • some participants were lost follow-up
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
97 Participants
n=97 Participants
|
54 Participants
n=54 Participants
|
151 Participants
n=151 Participants
|
PRIMARY outcome
Timeframe: At baseline and 12 months after the interventionCollected from blood test to assess the Glycosylated hemoglobin (HbA1c) levels
Outcome measures
| Measure |
Intervention Arm
n=65 Participants
The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management
TTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.
|
Control Arm
n=41 Participants
The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.
Usual care: Regular patient education on insulin injection at the control arm hospital.
|
|---|---|---|
|
Change in Glycosylated Hemoglobin (HbA1c) Levels
|
-1.47 percent of glycosylated Hb
Standard Deviation 2.23
|
-2.00 percent of glycosylated Hb
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: At baseline and 12 months after the interventionA 13-item Chinese version of the Diabetes Empowerment Process Scale was used to assess the perceived level of empowerment by healthcare providers in participants. Each item was rated on a 5-point scale with scores ranging from 0 (strongly disagree) to 4 (strongly agree). The total score range from 13 to 65. A higher score indicated higher perceived patient empowerment.
Outcome measures
| Measure |
Intervention Arm
n=65 Participants
The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management
TTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.
|
Control Arm
n=41 Participants
The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.
Usual care: Regular patient education on insulin injection at the control arm hospital.
|
|---|---|---|
|
Change in Diabetes Empowerment Process
|
0.52 score on a scale
Standard Deviation 12.13
|
-2.13 score on a scale
Standard Deviation 10.99
|
SECONDARY outcome
Timeframe: At baseline and 12 months after the interventionAn 8-item Chinese version of the short-form Problem Areas in Diabetes Scale was used to assess the levels of diabetes distress in participants. The response of each item was rated from 0 (not a problem) to 4 (serious problem). The total score ranged from 8 to 32. A higher score represented severer diabetes distress.
Outcome measures
| Measure |
Intervention Arm
n=65 Participants
The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management
TTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.
|
Control Arm
n=41 Participants
The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.
Usual care: Regular patient education on insulin injection at the control arm hospital.
|
|---|---|---|
|
Change in Diabetes Distress
|
-2.91 score on a scale
Standard Deviation 8.16
|
-3.63 score on a scale
Standard Deviation 6.76
|
SECONDARY outcome
Timeframe: At baseline and 12 months after the interventionA 15-item Diabetes-Specific Quality-of-Life Scale was used to assess the subjective appraisal of participants in their perceived degree to which their current health-related aspects in life were affected by emotional suffering, social functioning, adherence to treatment regimen, and diabetic-specific symptoms. Each item was rated from "very much" (0 point) to "not at all" (4 points). The total score ranged from 0 to 60. A higher score indicated better quality of life.
Outcome measures
| Measure |
Intervention Arm
n=65 Participants
The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management
TTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.
|
Control Arm
n=41 Participants
The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.
Usual care: Regular patient education on insulin injection at the control arm hospital.
|
|---|---|---|
|
Change in Quality of Life
|
2.6 score on a scale
Standard Deviation 7.51
|
5.45 score on a scale
Standard Deviation 10.86
|
SECONDARY outcome
Timeframe: At baseline and 12 months after the interventionPhysiological parameter which will be collected from body weight scale and height scale, and will be converted to body mass index (weight (kg)/ height(m) 2
Outcome measures
| Measure |
Intervention Arm
n=65 Participants
The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management
TTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.
|
Control Arm
n=41 Participants
The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.
Usual care: Regular patient education on insulin injection at the control arm hospital.
|
|---|---|---|
|
Change in Body Mass Index
|
1.06 Kg/m^2
Standard Deviation 1.61
|
0.85 Kg/m^2
Standard Deviation 1.81
|
Adverse Events
TTA Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ruey-Hsia Wang
College of Nursing,Kaohsiung Medical University
Phone: 886-3-3121101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place