Effects of Empowerment-based Program on Post-discharge Glycemic Control, and Foot Ulcer

NCT03993990 | Withdrawn

• 1 other identifier: 201802180B0
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate an empowerment-based program. A randomized controlled trial design will be used. From August 2019 to July 2021, 160 subjects will be recruited at a medical center and randomly assigned to the intervention or comparison group. Participants in the intervention group will receive an assessment of their self-care demand and self-efficacy, as well as an empowerment-based program delivered by the project host. The program includes the identification of the problems of participants, clarification of their feelings and the significance of their problems, plan setting discussion, motivation for action, and evaluation of the execution of their plan. Empowerment-based strategies will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, 42, 56, 70, and 84, and at 6, 9, and 12 months post-discharge. Those in the comparison group will receive routine care only. Outcome measures include self-care behaviors, glycemic control (measured by HbA1C), diabetic foot ulcer infection, and diabetic foot ulcer recurrence. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes、Foot ulcer、Self-care、glycemic control、Empowerment

Outcome Measures

Primary Outcomes (2)

• Glycemic control

  Glycated hemoglobin value

  Less than 1 minute

• Foot infection and recurrence of foot ulcer

  Foot assessment and the review of medical record

  5 minutes

Secondary Outcomes (7)

• Knowledge regarding warning signs of diabetic foot ulcer

  5 minutes

• Self-care behaviors of foot care

  3 minutes

• Self-care behaviors of diabetes

  4 minutes

• Diabetes-related Foot Ulcer Self-Management Behavior

  9 minutes

• Diabetes Management Self-Efficacy

  10 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants will receive an empowerment-based intervention individually, based on five steps (i. e. problem identification, meaning and perception clarification, intervention planning, intervention delivery, and evaluation).

Behavioral: individual empowerment-based intervention

Control group

NO INTERVENTION

Participants will receive routine care of the research setting only. The counseling will be provided if participants request.

Interventions

individual empowerment-based intervention BEHAVIORAL

Participants will receive an empowerment-based intervention individually, based on five steps (i. e. problem identification, meaning and perception clarification, intervention planning, intervention delivery, and evaluation). After the principal investigator delivers a pre-discharge assessment (i. e. the self-care behavior and self-efficacy of diabetes and diabetic foot ulcer, risk factors of foot ulcer, family support, and threat belief of participant), the plan of behavioral modification will be determined by the principal investigator and participants. The subsequent follow-up and intensifying interventions will be delivered at the following time points: three days after discharge, every weeks for one month, every two weeks for subsequent two months, and then every three months for three times.

Experimental group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes
• Age between 20 and 80 years old.
• Could communicate with Mandarin or Taiwanese.
• The glycated hemoglobin value is higher or equal to 7.5%.
• The vibration or monofilament test results are abnormal.
• Wagner stage 1 or 2 foot ulcer
• The location of ulcer is at the big toes or on the sole

You may not qualify if:

• Cognitive impairment
• Severe lower extremity arterial insufficiency disease
• Osteomyelitis or foot ulcer recurrent
• Alcoholism or Drug addiction
• Autoimmune disease
• Unable to perform daily self-care activity
• The main caregivers are foreigner and no other family members live together
• The C-reactive protein values are higher than 15 mg/dL
• Admitting in a long-term care institution after discharge from hospital
• No intention of the return-visit at the clinic of research hospital

Sponsors & Collaborators

• Chin yenfan: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Yenfan Chin, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: August 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)