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Pressure InjurySPIPENCT04944186

Effect of Structured Pressure Injury Patient Education

A study testing Structured Pressure Injury Patient Education (mySPIPE) and Standard Patient Education in people with Pressure Injury and Limitation, Mobility, run by University of Malaya at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pressure Injury, Limitation, Mobility
What is being tested?
Structured Pressure Injury Patient Education (mySPIPE) and Standard Patient Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteMalaysia
Study dates
8 Jul 2021to 25 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • Queen Elizabeth Hospital

    Kota Kinabalu, Sabah, 88586

Other trials in Malaysia

About this study

Official 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

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.

Read the detailed description

Patients with limited mobility and pressure injury are always at higher risk of having multiple functional, social, psychological, and financial repercussions. Without intensive PI management and prevention, these populations continue to suffer from prolonged pain, infection, social isolation, and exacerbation of mental health conditions.

While many preventive strategies and management are available to ease patient burden due to pressure injury, involving patient to take part in their care make a huge difference in patient outcome. In Malaysia, nurses play an important role in providing patient education on pressure injury, usually delivered through informal routine care, by distributing information leaflet or via digital resources on the Ministry of Health's website. However, the existing pressure injury education content is too broad, only emphasizing pressure injury prevention and no information on pressure injury care.

Few pieces of evidence reported on the effectiveness of patient education were able to improve patient knowledge on PI, increase patient participation in PI care associate with wound healing and improve the quality of life. However, there is a content gap in pressure injury patient education, which is wound care. While there a lot of patient education on pressure injury had been conducted extensively in the literature review, the components of wound care in pressure injury patient education are still unclear. Thus the primary objective of this study is to identify the effect of structured pressure injury patient education 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 compared to the standard patient education on patient's knowledge, participation, wound healing rate, and quality of life between control and intervention group over time.

To achieve this research objective, we opt to conduct a quasi-experimental study-calculation of sample size is by using STATA 12.0 program. To calculate the sample size, power at 80%, and alpha was pre-set at 0.05. Mean, and standard deviation (σ) were extracted from previous researcher. Based on the calculation, a total of 120 eligible samples will be recruited with 60 samples each arm.

The patients included in the study will be assigned to the experimental group (structured pressure injury patient education) and control group (standard patient education). Eight medical-surgical wards including rehabilitation ward with a high prevalence of pressure injury were identified and invited to participate. Four wards agreed (medical ward, two multidisciplinary wards, and orthopedic ward), and the rest unable to participates because allocated as active COVID-19 ward. Thus, potential participants for this study will be recruited in these four wards in this tertiary hospital. The process of data collection will be started with control group first and followed by intervention group. Considering the limited availability of the target population set in the inclusion criteria earlier, the researcher opts to use convenience sampling.

For the implementation of the study, permission was obtained from the Medical Research Ethical Committee of the Malaysian Ministry of Health. The patient included in the study sample will be informed before the study that the study's purpose and participation are voluntary, and the patient may withdraw at any time without penalties.

Data collection tools; In this study, a checklist and structured questionnaires will be used to measure the four outcomes of this research which are 1) knowledge, 2) participation, 3) wound healing progress, and 4) quality of life.

Personal Information Checklist:

Checklists consist of three parts: part I- patient health status, part II: Wound Healing Progress (PUSH Tool 3.0), and part III- Nutritional Assessment (MNA-SF). This checklist will be filled up by the wound care nurse at baseline (T0), week-4 (T1), and week-8 (T2). The wound care nurse will be given a briefing and manual on how to fill-up the form. The wound care nurse responsible for filling up the required checklist is not aware of the study hypothesis.

Part I: Patient health status - patient's registration ID, gender, ward, IC number, age, comorbidities, PI categories, and PI site.

Part II: Wound Healing Progress (PUSH Tools 3.0) - to measure PI healing progress. The total score will be ranging between 0 to 17, lower PUSH tools 3.0 indicate better-wound healing progress.

Part II: Nutritional Status (MNA-SF) - to determine the patient's current nutritional status. It is further be classified into three categories: normal nutritional status (12-14 points), at risk of malnutrition (8-11 points), and malnourished (0 - 7 points). Measure once at baseline.

Questionnaires Part I: Sociodemographic - sociodemographic characteristics, including seven components: age, socio-economic status, gender, level of education level, ethnicity, occupation, and marital status.

Part II: Knowledge on Prevention and Treatment on Pressure Injury - use to self-assess basic knowledge of the prevention and treatment of pressure injury using Skin-Management Needs Assessment Checklist. The total score is expressed as a percentage and interpreted as a higher score reflecting better knowledge.

Part III: Patient Participation - self-administered questionnaire by which patient will self-rate their active participation based on the given items. The total score is expressed as a percentage and interpreted as a higher score reflecting greater participation.

Part IV: Quality of Life - PU-QOL questionnaire is a PI-specific questionnaire that measuring how much does the occurrence of PI bothers their life. Scale scores are generated by summing items and then transforming them to a 0-100 scale. High scores indicate more excellent patient bother.

Descriptive analysis The sociodemographic data of the patient will be described as frequencies and percentages for categorical data; mean and standard deviation for continuous data. Descriptive analysis was used to estimate the score of each outcome (patient's knowledge, participation, wound healing progress, and quality of life). The Chi-square test was used to test the crude associations for categorical data. Comparison between two groups of continuous variables will be made using an independent t-test. All analysis will be conducted at a 5% significant level.

Analysis of efficacy The effectiveness of the intervention will be assessed using repeated measure analysis of covariance (ANCOVA), modeling the within-subject effects. Model fit will be determined using residual plots and lack-of-fit tests. The effect sizes of the ANCOVA will be interpreted according to Cohen (a partial η2 of .01 can be considered a small effect, a partial η2 of .06 can be considered a medium effect, and a partial η2 of .14 can be considered a significant effect).

Potential risk, benefit, and patient's safety All potential participants will be ensured that patient safety will be the priority upon conducting this study. Participation in this study will not affect their treatment, and the risk is very minimal. They are free to decline to answer any of the questions that they feel uncomfortable with. The benefit of the study may vary, as reported in previous research. However, the information obtained from this study will help the patient to gain more understanding on pressure injury, how to prevent pressure injury in the future from getting worse, and knowledge on pressure injury care. A booklet on pressure injury education as education material will also be provided to patients in both control and intervention groups for future references.

Being tested
Structured Pressure Injury Patient Education (mySPIPE), Standard Patient Education
Keywords
patient education, structured patient education, wound healing, quality of life
Medical subject headings
Pressure Ulcer, Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • Standard Patient EducationOther

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

Study groups in NCT04944186
Study groupRoleWhat they receive
Intervention GroupActive comparatorPatients 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.
Receives: Other: Structured Pressure Injury Patient Education (mySPIPE)
Control groupOtherPatients 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.
Receives: Other: Standard Patient Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knowledge

    Pressure Injury Knowledge (%)

    Measured: 8 weeks

  2. Patient Participation

    Patient Participation on Pressure Injury Prevention (%)

    Measured: 8 weeks

  3. 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.

    Measured: 8 weeks

  4. 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)

    Measured: 8 weeks

Secondary outcomes (4)
  1. 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.

    Measured: 8 weeks

  2. 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.

    Measured: 8 weeks

  3. 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.

    Measured: 8 weeks

  4. 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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2021
  2. Study start8 Jul 2021
  3. Primary completion17 Sep 2022
  4. Study completion25 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Prospective quasi-experimental study
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04944186
Sponsor's protocol ID
17033704
Acronym
SPIPE
Status last verified
Jul 2023
First submitted
16 Jun 2021
Last updated
18 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IDP sharing plan include a study protocol, statistical analysis plan, and informed consent form

Publications

  • 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.

    PubMed 26003919
  • 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.

    PubMed 27693836
  • 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.

    PubMed 31288977
  • 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.

    PubMed 28044436
  • 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.

    PubMed 27995939

Questions about this trial

What is this clinical trial studying?

A study testing Structured Pressure Injury Patient Education (mySPIPE) and Standard Patient Education in people with Pressure Injury and Limitation, Mobility, run by University of Malaya at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04944186, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.

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