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Completed

NCT Number: NCT07385833

Disaster Preparedness in Patients With Diabetic Foot: The Effect of an Educational Intervention

This quasi-experimental study aims to evaluate the effect of a disaster preparedness education program on disaster preparedness levels, foot care behaviors, and diabetic foot care self-efficacy in patients with type 2 diabetes diagnosed with diabetic foot. Participants are assigned to an intervention group receiving structured education on diabetic foot management and disaster preparedness, or to a control group receiving routine care. Outcomes are assessed at baseline, post-intervention, and follow-up.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Type 2 Diabetes Mellitus Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

About this study

Patients with diabetic foot are considered a vulnerable population during disasters due to disrupted access to healthcare, medications, and self-care resources. This study evaluates a structured disaster preparedness education program designed specifically for patients with diabetic foot. The intervention includes education on diabetic foot management, disaster preparedness strategies, and preparation of emergency kits and go-bags. The effects of the program on disaster preparedness, foot self-care behaviors, and self-efficacy are assessed using validated measurement tools across three time points. The findings aim to contribute to the development of disaster-focused educational interventions for individuals with chronic conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Diagnosed with type 2 diabetes mellitus for at least 6 months
  • Diagnosed with diabetic foot classified as Wagner grade 1, 2, or 3
  • Receiving outpatient or inpatient care at the diabetic foot center
  • Able to communicate and complete self-report questionnaires
  • Willing to participate and provide written informed consent

Exclusion criteria

  • • History of diabetic foot-related amputation
  • Presence of active Charcot neuroarthropathy
  • Severe cognitive impairment affecting participation
  • Significant communication barriers preventing completion of assessments
  • Presence of acute medical conditions requiring immediate intensive treatment during the study period

Treatment and study plan

Disaster Preparedness Education Program

Behavioral

The intervention consists of two face-to-face theoretical education sessions delivered over two weeks. Week 1 includes a 2-hour session on diabetic foot management (definition, risk factors, care principles) supported by visual materials and interactive Q&A. Week 2 includes a session on disaster and emergency management for individuals with diabetic foot, covering preparedness before disasters, actions during disasters, and post-disaster strategies to protect foot health. The contents of an emergency kit/go-bag are physically demonstrated, and participants are asked to prepare their own kit and bring it to the next visit. At post-test, emergency kits/go-bags are inspected using a standardized checklist and feedback is provided for missing or incorrect items.

Primary outcomes

  1. Change in Disaster Preparedness Level

    Time frame: Baseline, Week 3 (post-intervention), and Week 7 (follow-up)

    Disaster preparedness level is measured using the Disaster Preparedness Scale (DPS), a 15-item validated self-report scale assessing disaster physical protection, disaster planning, disaster assistance, and disaster warning and signals. Total scores range from 15 to 60, with higher scores indicating greater disaster preparedness. The primary outcome is the change in DPS total score from baseline.

Secondary outcomes

  1. Change in Diabetic Foot Care Self-Efficacy

    Time frame: Baseline, Week 3 (post-intervention), and Week 7 (follow-up

    Diabetic foot care self-efficacy is measured using the Diabetic Foot Care Self-Efficacy Scale (DFCSES), a validated self-report scale assessing confidence in performing diabetic foot care activities. Total scores range from 0 to 100, with higher scores indicating greater self-efficacy. The outcome is the change in DFCSES total score from baseline.

  2. Change in Foot Self-Care Behaviors

    Time frame: Baseline, Week 3 (post-intervention), and Week 7 (follow-up)

    Foot self-care behaviors are measured using the Foot Self-Care Behavior Scale (FSCBS), a validated 15-item scale assessing the frequency of diabetic foot care behaviors. Total scores range from 15 to 75, with higher scores indicating more positive foot self-care behaviors. The outcome is the change in FSCBS total score from baseline.

  3. Preparation of an Emergency Kit/Go-Bag

    Time frame: Week 3 (post-intervention)

    Preparation of an emergency kit/go-bag is assessed by direct inspection using a standardized checklist developed according to national and international disaster preparedness guidelines. The outcome is defined as the proportion of participants who prepared a complete emergency kit/go-bag following the educational intervention.

Sponsors and collaborators

Lead sponsor

Senem Duman

Other

Registry information

Acronym: Intervention

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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