The Effect of Message Framing in Diabetic Foot Self-Management

NCT06813794 | Enrolling By Invitation

• 1 other identifier: B.30.2.ATA.0.01.00/327
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess how effective gain- and loss-framed messages are in improving diabetic foot care behaviors and increasing self-efficacy levels compared to routine foot care messages. Study Design: A randomized controlled trial with three groups: Experimental Group 1 (Gain-Framed): Participants receive gain-framed messages emphasizing the benefits of proper foot care. Experimental Group 2 (Loss-Framed): Participants receive loss-framed messages highlighting the risks of inadequate foot care. Control Group (Routine Messaging): Participants receive standard foot care messages without specific framing. Participants: Diabetic patients recruited from Experimental Group 1, Experimental Group, and Control Group 3. Inclusion criteria include adults diagnosed with diabetes who are at risk for diabetic foot complications. Intervention: Over a period of three months, participants will receive WhatsApp messages three times a week. Gain-Framed Messages: Emphasize positive outcomes, such as preventing foot ulcers by wearing appropriate footwear. Loss-Framed Messages: Highlight negative consequences, such as the increased risk of foot infections from improper foot care. Messages will include supportive images and videos to enhance engagement and understanding. Outcome Measures: Primary Outcomes: Foot Care Behavior: Assessed using The Foot Care Behavior Scale. Self-Efficacy: Measured by the Diabetic Foot Care Self-Efficacy Scale Secondary Outcomes: Comparative effectiveness between gain-framed and loss-framed messages.Long-term behavioral changes post-intervention. Significance: This study seeks to determine the most effective messaging strategy to promote diabetic foot care, potentially informing future interventions to reduce the incidence of diabetic foot complications.

Conditions

Diabetes Mellitus

Keywords

message framing; Diabetic foot care; Self-efficacy

Outcome Measures

Primary Outcomes (2)

• Diabetic Foot Care Self-Sufficiency Level

  Diabetic Foot Care Self-Efficacy Scale will be applied to the patients in Experimental Group 1, Experimental Group 2 and Control Group 3. Primary Outcome: Change in Diabetic Foot Care Self-Efficacy Score from baseline to 3 months. Measurement Timepoints: Baseline (Pretest) and 3-Month Follow-up (Posttest).The lowest score that can be obtained from the Diabetic Foot Care Self-Efficacy Scale is 0 and the highest score is 90. As the score obtained from the scale increases, the level of diabetic foot self-efficacy increases.

  3 months

• Assessment of Foot Care Behavior

  Foot Care Behavior Scale will be applied to the patients in Experimental Group 1, Experimental Group 2 and Control Group 3. Primary Outcome: Change in Foot Care Behavior Scale from baseline to 3 months. Measurement Timepoints: Baseline (Pretest) and 3-Month Follow-up (Posttest).The lowest score of the Foot Care Behavior scale is 15 and the highest score is 75. The increase in the scale score indicates that the individual's self-care behaviors are better

  3 month

Study Arms (3)

Group 1 (Gain-Framed)

EXPERIMENTAL

Participants receive gain-framed messages emphasizing the benefits of proper foot care.

Behavioral: Gain- Framed Messages

Control Group

NO INTERVENTION

Participants will receive neutral messages about diabetic foot care.

Group 2 (Loss-Framed)

EXPERIMENTAL

Participants receive loss-framed messages highlighting the risks of inadequate foot care.

Behavioral: Lost Framed Messages

Interventions

Gain- Framed Messages BEHAVIORAL

Patients will be recruited to whatsapp group based on gain framing about diabetic foot care skills. Gain framing messages and videos will be delivered to patients via whatsapp 3 times a week for 3 months.

Group 1 (Gain-Framed)

Lost Framed Messages BEHAVIORAL

Patients will be included in whatsapp group based on Lost framing about diabetic foot care skills. Patients will receive loss framing messages and videos 3 times a week for 3 months via whatsapp.

Group 2 (Loss-Framed)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged between 18 and 55 years.
• Individuals diagnosed with diabetes for at least six months.
• Individuals without diabetic foot ulcers or amputations.
• Individuals without any communication disorders or psychiatric illnesses.
• Individuals who are members of a social media platform.
• Individuals who can use a smartphone and have internet access.
• Individuals willing to participate in the study.
• Individuals with at least a primary school education.

You may not qualify if:

• Individuals diagnosed with diabetes (This criterion seems unclear; please clarify if it should refer to a specific diabetes-related condition).
• Individuals with diabetic foot ulcers or amputations.
• Individuals with any communication disorders or psychiatric illnesses.
• Individuals without access to a smartphone or the internet.
• Individuals with malingering disorders.
• Individuals who are illiterate.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

Location

Related Publications (1)

• Gao R, Guo H, Liu Y, Pang Y, Zhang X, Lian X, Yu T, Zhu L, Li F. The effects of message framing on self-management behavior among people with type 2 diabetes: A randomized controlled trial. Int J Nurs Stud. 2023 Jun;142:104491. doi: 10.1016/j.ijnurstu.2023.104491. Epub 2023 Mar 17.

  PMID: 37059032 BACKGROUND

Related Links

• The International Working Group on the Diabetic Foot: Stories and Numbers Behind Three Decades of Evidence-Based Guidelines for the Management of Diabetes-Related Foot Disease

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mehtap Kavurmacı, Prof

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 7, 2025
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)