Pressure Injury Clinical Trial
— SPIPEOfficial title:
The Effect of Structured Pressure Injury Patient Education Program on Knowledge, Participation, Wound Healing Progress and Quality of Life Among Patient With Limited Mobility
Verified date | July 2023 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | September 25, 2022 |
Est. primary completion date | September 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Malaysia | Queen Elizabeth Hospital | Kota Kinabalu | Sabah |
Lead Sponsor | Collaborator |
---|---|
University of Malaya |
Malaysia,
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 tri — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. do — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knowledge | Pressure Injury Knowledge (%) | 8 weeks | |
Primary | Patient Participation | Patient Participation on Pressure Injury Prevention (%) | 8 weeks | |
Primary | 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 | |
Primary | 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 | Effectiveness of mySPIPE on PI knowledge | Effectiveness of mySPIPE on PI knowledge at week 4 and week 8. NAME OF MEASUREMENT : PI knowledge; MEASUREMENT TOOL - Questionnaire: Revised Skin-Management Needs Assessment Checklist (Revised SMNaC) ; UNIT OF MEASURE: Mean difference of PI knowledge at baseline (T0) to week 4 (T1), and Mean difference of PI knowledge from week 4 (T1) to week 8 (T2).
Minimum value = 10, Maximum value = 100; Higher score better outcome. |
8 weeks | |
Secondary | Effectiveness of mySPIPE on Patient participation on PI prevention | Effectiveness of mySPIPE on patient participation on PI prevention at week 4 and week 8. NAME OF MEASUREMENT : Patient participation on PI prevention; MEASUREMENT TOOL - Questionnaire: Patient Participation on PI prevention (PPPIP); UNIT OF MEASURE: Mean difference of PPPIP at baseline (T0) to week 4 (T1), and Mean difference of PPPIP from week 4 (T1) to week 8(T2).
Minimum value = 12.5, Maximum value = 100; Higher score better outcome. |
8 weeks | |
Secondary | Effectiveness of SPIPE on Wound Healing Progress | Effectiveness of SPIPE on Wound Healing Progress at week 4 and week 12. NAME OF MEASUREMENT : Wound Healing Progress; MEASUREMENT TOOL - Checklist : Pressure Ulcer Scale of Healing (PUSH 3.0); UNIT OF MEASURE: Mean difference of PUSH score at baseline (T0) to week 4 (T1), and Mean difference of PUSH score from week 4 (T1) to week 8 (T2).
Minimum value = 0, Maximum value = 17; Lower score better outcome. |
8 weeks | |
Secondary | Effectiveness of mySPIPE on Pressure ulcer-specific symptoms and functional outcomes | Effectiveness of mySPIPE on Pressure ulcer-specific symptoms and functional outcomes at week 4 and week 8.
NAME OF MEASUREMENT: Quality of Life; MEASUREMENT TOOL - Questionnaire: Pressure Ulcer Quality of Life (PUQOL); UNIT OF MEASURE: Mean difference of PUQOL at baseline (T0) to week 4 (T1), and Mean difference of PUQOL score from week 4 (T1) to week 8 (T2). Minimum value = 0, Maximum value = 100; Higher score better outcome. |
8 weeks |
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