OstomyNCT03841071
A Clinical Feedback System in Ostomy Care
An observational study of Ostomy and Quality of Life, run by Helse Forde at 1 site in Norway.
Trial summary
Background: Living with an ostomy can be challenging and adapting to life with an ostomy can be particularly complex, with regard to both the physical and psychosocial aspects. Follow-up with a stoma care nurse is usually performed after surgery to support the adaptation process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy, Quality of Life, Adaptation, Psychological
- What is being tested?
- ROM/CFS intervention
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2018to 1 Jun 2021
- Phase
- Observational
- 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
Study population: Patients who have undergone urostomy, colostomy, or ileostomy operations, and who are included in the routine follow-up program at a outpatient ostomy clinic.
Who may be able to join
- >18 years of age
- Living with a colostomy, ileostomy, or urostomy for a minimum of 3 months
- Being able to read and write Norwegian
Who cannot join
- < The 3 weeks follow-up after surgery are not included
- Patients who have their ostomy removed <12 months after surgery
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Førde Hospital Trust
Førde, 6812
Kirsten L Indrebø, McS
About this study
Official title: Use of the Ostomy Adjustment Scale (OAS) as a Routine Outcome Measure of Adaptation to Life With an Ostomy Along With a Clinical Feedback System in the Follow-up of Ostomy Patients; Does it Promote Adaptation to the Life With an Ostomy?
Background: Living with an ostomy can be challenging and adapting to life with an ostomy can be particularly complex, with regard to both the physical and psychosocial aspects. Follow-up with a stoma care nurse is usually performed after surgery to support the adaptation process. In this project, we describe a new model of ostomy care, where a clinical feedback system (CFS) is implemented in order to improve the adaption process of patients with an ostomy. We also present a plan for evaluating patients experience with the CFS and their clinical outcomes.
Methods: We include patients who had recently performed colostomy, ileostomy, or urostomy surgery. The intervention includes self-reported measures for adaptation to life with an ostomy and health-related quality of life (HRQoL), as well as patient experiences and satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings. Patient experiences and satisfaction with care will be measured with the Generic Short Patient Experiences Questionnaire. Adaptation to the life with ostomy will be measured with the Ostomy Adjustment Scale, and HRQoL with the Short Form 36.
Discussion: This study presents a novel approach that could lead to improved consultation, more patient involvement, and better adaptation to life with an ostomy.
Read the detailed description
The study protocol is avaliable on request, and will also be published in a open acsess peer-reviewed journal.
- Conditions
- Ostomy, Quality of Life, Adaptation, Psychological
- Being tested
- ROM/CFS intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROM/CFS interventionOther
The intervention (ROM/CFS) includes self-reported measures for adaptation to life with an ostomy and health-related quality of life, as well as patient satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery, and annually thereafter. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings.
| Study group | Role | What they receive |
|---|---|---|
| ROM/CFS intervention | The ROM/CFS group (N>100), consists of patients who have undergone urostomy, colostomy, or ileostomy operations, and who are included in the routine follow-up program of the outpatient ostomy clinic at the Department of Surgery, Førde Central Hospital from April 2018 to June 2021. Receives: Other: ROM/CFS intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient's subjective adaptation to the physical, psychological, and social changes that occur after ostomy surgery
The summary score of the Ostomy Adjustment Scale (lowest possible score is 34 and the highest 204). Higher scores represent better outcomes.
Measured: From the 3 months follow-up after surgery to the 12 months follow-up.
Secondary outcomes (1)
Generic health-related quality of life
The two summary scores of the Short Form-36 (Physical Component Score and Mental Component Score). The lowest possible score is 0 and the highest 100. Higher scores represent better outcomes.
Measured: From the 3 months follow-up after surgery to the 12 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Apr 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OstomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Forde
- Sponsor type
- University, hospital or other
- Collaborators
- Western Norway University of Applied Sciences, Norwegian Nurses Organisation
- Responsible party
- Sponsor
- Investigators
- John R Andersen, PhD, Principal investigator, Førde Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841071
- Sponsor's protocol ID
- 2016255
- Other IDs
- 2016255
- Status last verified
- Oct 2019
- First submitted
- 8 Feb 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset generated during this study will not be publicly available as the patient consent and approval from the Regional Committee for Medical and Health Research Ethics prevents sharing of individual patient level data in public repositories. However, the data will be available from the corresponding author upon reasonable request.
Publications
Indrebo KL, Aasprang A, Olsen TE, Andersen JR. Factors associated with leakage in patients with an ostomy: A cross-sectional study. Nurs Open. 2023 Jun;10(6):3635-3645. doi: 10.1002/nop2.1612. Epub 2023 Jan 24.
PubMed 36691880Indrebo KL, Aasprang A, Olsen TE, Andersen JR. Psychometric Properties of New Subscales of the Ostomy Adjustment Scale: A Cross-Sectional Study. Patient Relat Outcome Meas. 2021 Mar 15;12:65-75. doi: 10.2147/PROM.S300604. eCollection 2021.
PubMed 33758568Indrebo KL, Aasprang A, Olsen TE, Andersen JR. A new model of patient-reported outcome monitoring with a clinical feedback system in ostomy care: rationale, description and evaluation protocol. Health Qual Life Outcomes. 2020 Jan 15;18(1):12. doi: 10.1186/s12955-019-1261-3.
PubMed 31941516
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Ostomy Adjustment Scale (OAS) as a Routine Outcome Measure of Adaptation to Life With an Ostomy Along With a Clinical Feedback System in the Follow-up of Ostomy Patients; Does it Promote Adaptation to the Life With an Ostomy?
- ClinicalTrials.gov ID
- NCT03841071
- Acronym / sponsor ID
- 2016255
- Conditions
- Ostomy, Quality of Life, Adaptation, Psychological
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helse FordeUniversity, hospital or other
- Collaborators
- Western Norway University of Applied Sciences, Norwegian Nurses Organisation
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Living with an ostomy can be challenging and adapting to life with an ostomy can be particularly complex, with regard to both the physical and psychosocial aspects. Follow-up with a stoma care nurse is usually performed after surgery to support the adaptation process. In this project, we describe a new model of ostomy care, where a clinical feedback system (CFS) is implemented in order to improve the adaption process of patients with an ostomy. We also present a plan for evaluating patients experience with the CFS and their clinical outcomes.
Methods: We include patients who had recently performed colostomy, ileostomy, or urostomy surgery. The intervention includes self-reported measures for adaptation to life with an ostomy and health-related quality of life (HRQoL), as well as patient experiences and satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings. Patient experiences and satisfaction with care will be measured with the Generic Short Patient Experiences Questionnaire. Adaptation to the life with ostomy will be measured with the Ostomy Adjustment Scale, and HRQoL with the Short Form 36.
Discussion: This study presents a novel approach that could lead to improved consultation, more patient involvement, and better adaptation to life with an ostomy.
Detailed description
The study protocol is avaliable on request, and will also be published in a open acsess peer-reviewed journal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ROM/CFS intervention | – | Other: ROM/CFS interventionThe ROM/CFS group (N>100), consists of patients who have undergone urostomy, colostomy, or ileostomy operations, and who are included in the routine follow-up program of the outpatient ostomy clinic at the Department of Surgery, Førde Central Hospital from April 2018 to June 2021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone urostomy, colostomy, or ileostomy operations, and who are included in the routine follow-up program at a outpatient ostomy clinic.
Key inclusion criteria (3 listed)
- >18 years of age
- Living with a colostomy, ileostomy, or urostomy for a minimum of 3 months
- Being able to read and write Norwegian
Key exclusion criteria (2 listed)
- < The 3 weeks follow-up after surgery are not included
- Patients who have their ostomy removed <12 months after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROM/CFS interventionThe intervention (ROM/CFS) includes self-reported measures for adaptation to life with an ostomy and health-related quality of life, as well as patient satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery, and annually thereafter. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings. | Other | ROM/CFS intervention |
Primary outcome
The patient's subjective adaptation to the physical, psychological, and social changes that occur after ostomy surgery
Time frame: From the 3 months follow-up after surgery to the 12 months follow-up.
The summary score of the Ostomy Adjustment Scale (lowest possible score is 34 and the highest 204). Higher scores represent better outcomes.
1 secondary outcome
Generic health-related quality of life
Time frame: From the 3 months follow-up after surgery to the 12 months follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Derived from this study: PubMed 36691880Indrebo KL, Aasprang A, Olsen TE, Andersen JR. Factors associated with leakage in patients with an ostomy: A cross-sectional study. Nurs Open. 2023 Jun;10(6):3635-3645. doi: 10.1002/nop2.1612. Epub 2023 Jan 24.
- Derived from this study: PubMed 33758568Indrebo KL, Aasprang A, Olsen TE, Andersen JR. Psychometric Properties of New Subscales of the Ostomy Adjustment Scale: A Cross-Sectional Study. Patient Relat Outcome Meas. 2021 Mar 15;12:65-75. doi: 10.2147/PROM.S300604. eCollection 2021.
- Derived from this study: PubMed 31941516Indrebo KL, Aasprang A, Olsen TE, Andersen JR. A new model of patient-reported outcome monitoring with a clinical feedback system in ostomy care: rationale, description and evaluation protocol. Health Qual Life Outcomes. 2020 Jan 15;18(1):12. doi: 10.1186/s12955-019-1261-3.
- Study approval from the Regional Committees for Medical and Health Research Ethics (REC)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The dataset generated during this study will not be publicly available as the patient consent and approval from the Regional Committee for Medical and Health Research Ethics prevents sharing of individual patient level data in public repositories. However, the data will be available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Andersen, PhD principal investigator
Førde Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ostomy and Quality of Life, run by Helse Forde at 1 site in Norway.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Oct 2019. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirsten L Indrebø, McS (4795966010, kirsten.lerum.indrebo@helse-forde.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patient's subjective adaptation to the physical, psychological, and social changes that occur after ostomy surgery (time frame: From the 3 months follow-up after surgery to the 12 months follow-up.). 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 NCT03841071, which also lists 3 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 25 Oct 2019.