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The aim of the study is to assess the effectiveness of an intervention for insulin injection initiation based on the Transtheoretical Model (TTM) for insulin-naïve patients with type 2 diabetes mellitus (T2DM).
According to the Transtheoretical Model (TTM) proposed by Prochaska and Diclemente, people will experience different stages of change before the actual behavioral change takes place. Ineffectiveness of intervention to instigate behavioral change is largely due to failure to take into account the stage of change in which individuals are. The TTM suggests that decisional balance, which reflects the relative difference between pros and cons, is important for influencing the stage of change. In order to achieve behavioral change, the perceived pros of changing must be strengthened to outweigh the cons. In addition, individual must be self-convinced that the behavioral change is important for themselves. Furthermore, the process for behavioral change can be provided to facilitate behavioral change in individuals. The theory of TTM has yet been used to improve the behavior of insulin initiation in insulin-naïve patients with T2DM. Thus, this study aims to assess the effectiveness of an intervention for insulin injection initiation based on the TTM in insulin-naïve patients with T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management |
|
| Control arm | Placebo Comparator | The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTM Intervention for Insulin Initiation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) Levels | Collected from blood test to assess the Glycosylated hemoglobin (HbA1c) levels | At baseline and 12 months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Empowerment Process | A 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. |
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Inclusion Criteria:
(1) diagnosed with T2DM for at least half a year; (2) aged 20-70 years old; (3) controlling diabetes only through oral medication, without previous experience in insulin injection; (4) HbA1c≧8.5% as measured more than twice in a year; (5) considered suitable and recommended by the doctor to initiate insulin injection.
Exclusion Criteria:
(1) unable to communicate with language; (2) incapable of self-administering insulin injection due to visual or muscular impairment.
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| Name | Affiliation | Role |
|---|---|---|
| Ruey-Hsia Wang, PhD | Kaohsiung Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lee's clinic | Kaohsiung City | 807 | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | some participants were lost |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycosylated Hemoglobin (HbA1c) Levels | Collected from blood test to assess the Glycosylated hemoglobin (HbA1c) levels | Posted | Mean | Standard Deviation | percent of glycosylated Hb | At baseline and 12 months after the intervention |
|
the adverse event data were collected at 12 months after intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TTA Intervention | The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruey-Hsia Wang | College of Nursing,Kaohsiung Medical University | 886-3-3121101 | 2641 | wrhsia@kmu.edu.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2017 | Oct 24, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Patients with T2DM at a clinic in southern Taiwan are assigned to the intervention arm, whereas patients with T2DM at the endocrinology department of a hospital in northern Taiwan are placed in the control arm. Eligible patients that match the inclusion criteria are recommended by doctors to initiate insulin treatment. Research assistants will explain the objectives of this study to eligible participants. Subsequently, baseline data will be collected from participants by research assistants after the participants sign the consent forms. Afterwards, the participants in the intervention arm will receive the intervention. For the control arm, the participants will receive regular patient education originally administered at the hospital.
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| Usual care | Behavioral | Regular patient education on insulin injection at the control arm hospital. |
|
| At baseline and 12 months after the intervention |
| Change in Diabetes Distress | An 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. | At baseline and 12 months after the intervention |
| Change in Quality of Life | A 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. | At baseline and 12 months after the intervention |
| Change in Body Mass Index | Physiological 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 | At baseline and 12 months after the intervention |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | some participants were lost follow-up | Mean | Standard Deviation | years |
|
| Sex: Female, Male | some participants were lost follow-up | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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.
|
|
| Secondary | Change in Diabetes Empowerment Process | A 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. | Posted | Mean | Standard Deviation | score on a scale | At baseline and 12 months after the intervention |
|
|
|
| Secondary | Change in Diabetes Distress | An 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. | Posted | Mean | Standard Deviation | score on a scale | At baseline and 12 months after the intervention |
|
|
|
| Secondary | Change in Quality of Life | A 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. | Posted | Mean | Standard Deviation | score on a scale | At baseline and 12 months after the intervention |
|
|
|
| Secondary | Change in Body Mass Index | Physiological 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 | Posted | Mean | Standard Deviation | Kg/m^2 | At baseline and 12 months after the intervention |
|
|
|
| 0 |
| 97 |
| 0 |
| 97 |
| 0 |
| 97 |
| EG001 | Control Arm | Participants in the control arm receives regular patient education. | 0 | 54 | 0 | 54 | 0 | 54 |
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| D004700 | Endocrine System Diseases |