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A Qualitative Phase 1 Study to Development a New Patient-Reported Outcome Instrument for Acute and Chonic Wounds: The WOUND-Q

A Qualitative Phase 1 Study to Development a New Patient-Reported Outcome Instrument for Acute and Chonic Wounds: The WOUND-Q - The WOUND-Q Phase 1

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45641
Enrollment
15
Registered
2017-02-02
Start date
2017-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic wounds

Interventions

Sponsors

Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: patients aged 18 and older with any type of chronic wound (> 3 months) anywhere on their body;Patients will be recruited from the out-patient clinic of the Plastic Surgery department, Catharina Hospital Eindhoven. Sampling will be purposeful and will consist of a heterogeneous maximum variation sample to ensure we hear as many patient stories as possible. Included patients will have are those who have received treatment for an acute or chronic wounds. ;We will strive to recruit a sample that varies by gender, age, ethnicity, type of acute or chronic would, location of wound on body, phase in the wound healing process and risk of poor outcome including older age, smoking having diabetes or being obese.

Exclusion criteria

Exclusion criteria: Patients who do not speak Dutch and/or have cognitive or developmental delay will be excluded.

Design outcomes

Primary

MeasureTime frame
Interviews, coding and item generation: The study RA will conduct the interviews (see Table 3 for Interview Guide), which will be tape recorded and transcribed verbatim. The data will be coded using a line-by-line approach where all concepts are labelled with a major and minor COI. Coding will take place as soon as possible after an interview so that findings can inform subsequent interviews in an iterative fashion. Item generation will also take place concurrently with data collection. This process will occur within Excel. Codes (patient quotes) and their major and minor COI will be moved from the Word document into Excel columns. Patient characteristics (e.g., age, health condition, wound type, healing phase) will also be inserted into Excel columns. These characteristics will make it possible for us to identify potential core items (common across wound type) and unique items (specific to a wound type). For each code, preliminary items will be generated and each will be assigned a descriptor to capture the essence of what it measures. Items will retain the wording used by patients and have the lowest possible grade reading level to ensure the content resonates with patients and is comprehensible.

Secondary

MeasureTime frame
After completing phase 1 we will continue with phase 2 and 3 (not part of this application). We anticipate that the WOUND-Q will provide the international medical community with meaningful, precise and reliable feedback on important patient-centered outcomes and the potential for widespread use in both clinical and research settings.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)