Effect of Structured Pressure Injury Patient Education

NCT04944186 | Completed DMC

• 1 other identifier: 17033704
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned as a prospective quasi-experimental study with the control group to determine the effect of structured pressure injury patient education (program on the knowledge, participation, wound healing progress, and quality of life among patients with limited mobility. We hypothesized that there would be a significant effect of structured pressure injury patient education on patient's knowledge, participation, wound healing rate, and quality of life between the control and intervention group over time.

Conditions

Pressure Injury; Limitation, Mobility

Keywords

patient education; structured patient education; wound healing; quality of life

Outcome Measures

Primary Outcomes (4)

• Knowledge

  Pressure Injury Knowledge (%)

  8 weeks

• Patient Participation

  Patient Participation on Pressure Injury Prevention (%)

  8 weeks

• Wound-healing progress

  Pressure injury condition includes size, exudate and tissue type (Score 0 -17). 0 minimum points indicate wound completely heal. Increasing number of score indicate wound condition is worsening. 17 maximum points represents a serious PI with wound area more than 24cm2 of of size, heavy exudate, and non-viable tissue.

  8 weeks

• Pressure ulcer-specific symptoms and functional outcomes

  Pressure ulcer-specific symptoms and functional outcomes is assessed by the Pressure Ulcer Quality of Life (PU-QOL)

  8 weeks

Secondary Outcomes (4)

• Effectiveness of mySPIPE on PI knowledge

  8 weeks

• Effectiveness of mySPIPE on Patient participation on PI prevention

  8 weeks

• Effectiveness of SPIPE on Wound Healing Progress

  8 weeks

• Effectiveness of mySPIPE on Pressure ulcer-specific symptoms and functional outcomes

  8 weeks

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Patients in the experimental group will receive structured pressure injury patient education. It is consists of 2 sessions followed by biweekly follow-up for 8-week. The first session lasts for two days; the duration is 80 minutes (40 minutes /day for two days). Method of delivery is face to face, one to one with the aid of PowerPoint presentation and booklet. In the second session, the duration remains the same (80 minutes; 40 minutes/day for 2 days). The method of delivery also the same but teaching aid video presentation will be used. Three videos with a duration of approximately 2 - 3 minutes. In the second session, participants will be given a task to perform and document in the booklet given to monitoring its adherence. Upon completion of the two sessions, the patient will be follow-up biweekly and monitored their progress.

Other: Structured Pressure Injury Patient Education (mySPIPE)

Control group

OTHER

Patients in this group shall continue with the standard patient education in the ward. Standard patient education routinely delivers through an informal verbal method after wound dressing is done.

Other: Standard Patient Education

Interventions

Structured Pressure Injury Patient Education (mySPIPE) OTHER

It consists of PI education topics which include four main topics; 1) Pressure Injury: Why Me, which will be covering the basic information that patient need to know about PI; 2) Look After Your Skin, in this topics, patient will be thought about how skin checking was done and why it need to be done; 3) Preventing pressure injury, in this topic, patient will be emphasized on the suitable repositioning for them and the benefit of support surfaces and preventive wound dressing; 4) Help your PI heal, in this topic patient will be guided on what are condition that help PI healing and dietary needs to support wound healing

Intervention Group

Standard Patient Education OTHER

No fixed content/ duration of patient education. Basically, patient repositioning emphasized verbally after wound dressing completed.

Control group

Eligibility Criteria

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

You may qualify if:

• Patient must be literate in either Malay or English language.
• Patients with PI stage II or stage III according to NPIAP staging of PI.
• PI located either at sacrococcygeal / greater trochanter/ischial tuberosities.
• Braden score 18 or less; with limited mobility
• Absence of any active malignant, hematological problem or psychiatric disease

You may not qualify if:

• Immunocompromised
• Having urinary/fecal incontinence
• Comatose patient or who are unable to respond verbally and cognitively impaired
• Patient who will undergo flap or skin graft surgery

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Queen Elizabeth Hospital

Kota Kinabalu, Sabah, 88586, Malaysia

Location

Related Publications (5)

• Chaboyer W, Bucknall T, Webster J, McInnes E, Banks M, Wallis M, Gillespie BM, Whitty JA, Thalib L, Roberts S, Cullum N. INTroducing A Care bundle To prevent pressure injury (INTACT) in at-risk patients: A protocol for a cluster randomised trial. Int J Nurs Stud. 2015 Nov;52(11):1659-68. doi: 10.1016/j.ijnurstu.2015.04.018. Epub 2015 May 11.

  PMID: 26003919 BACKGROUND

• Chaboyer W, Bucknall T, Webster J, McInnes E, Gillespie BM, Banks M, Whitty JA, Thalib L, Roberts S, Tallott M, Cullum N, Wallis M. The effect of a patient centred care bundle intervention on pressure ulcer incidence (INTACT): A cluster randomised trial. Int J Nurs Stud. 2016 Dec;64:63-71. doi: 10.1016/j.ijnurstu.2016.09.015. Epub 2016 Sep 23.

  PMID: 27693836 BACKGROUND

• Robineau S, Nicolas B, Mathieu L, Durufle A, Leblong E, Fraudet B, Gelis A, Gallien P. Assessing the impact of a patient education programme on pressure ulcer prevention in patients with spinal cord injuries. J Tissue Viability. 2019 Nov;28(4):167-172. doi: 10.1016/j.jtv.2019.06.001. Epub 2019 Jun 22.

  PMID: 31288977 RESULT

• Kim JY, Cho E. Evaluation of a self-efficacy enhancement program to prevent pressure ulcers in patients with a spinal cord injury. Jpn J Nurs Sci. 2017 Jan;14(1):76-86. doi: 10.1111/jjns.12136. Epub 2016 Jul 7.

  PMID: 28044436 RESULT

• Arora M, Harvey LA, Glinsky JV, Chhabra HS, Hossain S, Arumugam N, Bedi PK, Lavrencic L, Hayes AJ, Cameron ID. Telephone-based management of pressure ulcers in people with spinal cord injury in low- and middle-income countries: a randomised controlled trial. Spinal Cord. 2017 Feb;55(2):141-147. doi: 10.1038/sc.2016.163. Epub 2016 Dec 20.

  PMID: 27995939 RESULT

MeSH Terms

Conditions

Pressure Ulcer; Mobility Limitation

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Deena C Thomas, MNSc

  University of Malaya

  PRINCIPAL INVESTIGATOR

• Chui Ping Lei, PhD

  University of Malaya

  STUDY DIRECTOR

• Abqariyah Yahya, PhD

  University of Malaya

  STUDY CHAIR

• Alan Yap Jiann Wen, MSc; MD

  Ministry of Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective quasi-experimental study

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 29, 2021
• Study Start: July 8, 2021
• Primary Completion: September 17, 2022
• Study Completion: September 25, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: October 2021 for 12 months
• Access Criteria: Access granted upon request via direct email dnaclare@ums.edu.my

Locations

MY (1)