NCT03728647

Brief Summary

A total of 72 type 2 diabetes who began insulin therapy using a pen injector participated in this study. The experimental (n = 36) and control (n = 36) groups received multimedia and regular health education program. Four structured questionnaires were used, and videotapes were applied to demonstrate injection skills.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2014

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
Last Updated

November 2, 2018

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

October 28, 2018

Last Update Submit

November 1, 2018

Conditions

Outcome Measures

Primary Outcomes (5)

  • diabetes and insulin injection related knowledge scale

    The 20-item diabetes and insulin injection related knowledge scale consists of 4 domains: brief introduction to diabetes, precautions for diabetes medications and insulin injection, management of hyper- and hypoglycemia, and complications of diabetes. Total scores ranged from 0 to 20. Higher scores represent a better outcome.

    Change from Baseline diabetes and insulin injection related knowledge to the thirteenth week after discharge from hospital

  • insulin injection skills scale

    The insulin injection skills scale was rated by a certified diabetes educator according to each participant's performance on the 12 steps of operating a prefilled pen injector (12 items; scores ranged from 0 to 12) and the 10 steps of operating a disposable pen injector (10 items; scores ranged from 0 to 10 ). Participants scored 1 point for each correct operation and 0 points for each incorrect operation. Higher scores represent a better outcome.

    Change from Baseline insulin injection skills to the thirteenth week after discharge from hospital

  • self-efficacy in insulin injection scale

    The 10-item self-efficacy in insulin injection scale was modified based on the General Self-Efficacy Scale. Total scores ranged from 10 to 50. Higher scores represent a better outcome.

    Change from Baseline self-efficacy in insulin injection to the thirteenth week after discharge from hospital

  • The health education satisfaction scale

    The 10 items health education satisfaction scale consisted of 10 items, with total scores ranging from 10 to 50. Higher scores represent a better outcome.

    Change from the day prior to discharge satisfaction with health education to the thirteenth week after discharge from hospital

  • nursing hours

    The nursing hours were calculated by adding up the total time spent by the diabetes educator instructing each participant to perform insulin injection.

    Through intervention to the day prior to discharge from hospital, an average of 1 week

Secondary Outcomes (3)

  • glycated hemoglobin(HbA1C)

    Change from Baseline HbA1C to the thirteenth week after discharge from hospital

  • blood creatinine

    Change from Baseline blood creatinine to the thirteenth week after discharge from hospital

  • insulin performance rate

    Change from the first week after discharge insulin performance rate from hospital to the thirteenth week after discharge

Study Arms (2)

multimedia health education

EXPERIMENTAL

The program (flat touch computer) consisted of knowledge and technology levels. Knowledge: diabetic introduction, treatment, management of hyper- and hypoglycemia, complications, and experience sharing of insulin injection by a patient group. Technology: steps of insulin injection skills and complete technology demonstration . The program contents were organized using a unit-based piecemeal teaching approach. Participants could adjust their learning pace according to individual situations and could practice injection skills using an injection mold during hospitalization. A diabetes educator has assessed the learning outcome of each participant after intervention. At the day of discharge from hospital, each participant would acquire a copy of the multimedia health education compact disc.

Behavioral: multimedia health education

regular health education

ACTIVE COMPARATOR

The regular (traditional) education program (a diabetes educator) consisted of knowledge and technology levels. Knowledge: diabetic introduction, treatment, management of hyper- and hypoglycemia, and complications. Technology: steps of insulin injection skills and complete technology demonstration.

Behavioral: regular health education

Interventions

The program (flat touch computer) consisted of knowledge and technology levels. Knowledge: diabetic introduction, treatment, management of hyper- and hypoglycemia, complications, and experience sharing of insulin injection by a patient group. Technology: steps of insulin injection skills and complete technology demonstration . The program contents were organized using a unit-based piecemeal teaching approach. Participants could adjust their learning pace according to individual situations and could practice injection skills using an injection mold during hospitalization. A diabetes educator has assessed the learning outcome of each participant after intervention. At the day of discharge from hospital, each participant would acquire a copy of the multimedia health education compact disc.

multimedia health education

The traditional education program (a diabetes educator) consisted of knowledge and technology levels. Knowledge: diabetic introduction, treatment, management of hyper- and hypoglycemia, and complications. Technology: steps of insulin injection skills and complete technology demonstration.

regular health education

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 diabetes.
  • First received insulin injection with Lantus, Levemir or Novomix.
  • Ability to communicate in Mandarin or Taiwanese.
  • Ability to self-inject insulin.

You may not qualify if:

  • Cognitive impairment or dementia, inability to manage self-care.
  • Severe or unstable medical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Mei-Chuan Huang, PHD

    National Tainan Junior College of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study used a randomized repeated-measures experimental design. The experimental group received a multimedia health education program and the control group received a regular health education program.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2018

First Posted

November 2, 2018

Study Start

August 16, 2013

Primary Completion

August 31, 2014

Study Completion

August 31, 2014

Last Updated

November 2, 2018

Record last verified: 2013-08

Data Sharing

IPD Sharing
Will not share