ColostomyNCT01154725
The Effect of Patient Education and Rehabilitation on Quality of Life in Patients With Permanent Stomas
A study testing Patient education and rehabilitation and habitual patient education in people with Colostomy, run by Herlev Hospital at 2 sites in Denmark.
Trial summary
The purpose of the experiment is to study the effect it has on patients' quality of life if they go through a structured process marked by intensified and specialized effort by ostomy nurse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy
- What is being tested?
- Patient education and rehabilitation and habitual patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesDenmark
- Study dates
- Aug 2010to Mar 2012
- 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
- All patients with permanent or temporary stomas regardless of cause that are expected to be able to cooperate in filling out questionnaires and who will participate in the planned interventions.
Who cannot join
- Patients that post-operatively are not able to cooperate and participate in the planned interventions.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Surgery, Herlev University Hospital
Herlev, 2730
Herlev University Hospital
Herlev, 2730
About this study
Official title: Effect of Patient Education and Rehabilitational Interventions on Health Related Quality of Life of Patients With Permanent Stomas Regardless of Cause
The purpose of the experiment is to study the effect it has on patients' quality of life if they go through a structured process marked by intensified and specialized effort by ostomy nurse. This includes close monitoring during hospitalization, telephone contact and guidance following discharge and participation in a group based patient school up to 4 months after discharge .
At the same time the study also examines what the economic effect of following the intervention will have.
Read the detailed description
Construction of an ostomy is a radical treatment with permanent physical signs of body alteration. It leads to loss of a central and very personal bodily function (excretion of faeces through the rectum) and there is a significant change in personal hygiene.
Having a colostomy is not a uniform state but is characterized by many different factors: Several types of ostomy, several underlying causes that lead to stoma creation such as cancer, several individual psychosocial profile, which naturally affect individuals differently. Patients are forced to living with a changed body image, a change in daily routines, and for some there will also be changes in lifestyle, social standing and their sexuality will be affected. At the same time patients experience a break when they are discharged from the hospital, and they may lack the practical and emotional support.
The training and education of patients is increasingly being carried out by stoma nurses both in Denmark and internationally. The primary role is to inform and prepare patients before surgery and to keep the contact with patients after surgery to ensure the fulfillment of the patient´s independent and meaningful life after ostomy construction. It is assumed that ostomy nurse's intervention and involvement are important for the patient's quality of life, but there are no studies that uniquely identifies the type of education that has the greatest effect, which applies both to content and methods.
Quality of life measurement in health care is a merging method to ensure the patient´s perspective on health treatments.It is greatly needed to test the efficacy of nursing interventions on patients' quality of life. Pressure on health services increase which makes it imperative also to include analysis and calculation of economic effect of the intervention.
- Conditions
- Colostomy
- Being tested
- Patient education and rehabilitation, habitual patient education
- Keywords
- Patient education, Health-Related Quality of Life, patients with stomas, stomatherapy, health economics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education and rehabilitationBehavioural
Also called health related quality of life, patient education, stoma care, stomatherapy
Patients in the experimental group will receive specialized and optimized care by stoma care nurses. This includes one-on-one guiding during the hospitalization, guidance by telephone after discharge and participation in patient education 3 times after discharge.
habitual patient educationBehavioural
habitual patient education
| Study group | Role | What they receive |
|---|---|---|
| Habitual stoma care | Other | habitual patient education Receives: Behavioral: habitual patient education |
| Patient education and rehabilitation | Experimental | patient education and rehabilitation Receives: Behavioral: Patient education and rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ostomy Adjustment Scale measurement of quality of life
the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.
Measured: 6 months (+/- 2 weeks) postoperatively
Secondary outcomes (4)
Economic effect
The investigators will monitor readmittance and contacts and diagnostic procedures and therapeutic interventions related to stoma creation during the period from admittance to hospital until 6 months after discharge.
Measured: 6 months after discharge
Ostomy Adjustment Scale and SF-36 measurement of quality of life
the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.
Measured: 3 months (+/-2 weeks) postoperatively
Ostomy Adjustment Scale and SF-36 measurement of quality of life
the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.
Measured: 3-7 days postoperatively before discharge
SF-36 measurement of quality of life
the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.
Measured: 6 months (+/- 2 weeks) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ColostomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Kjærgaard Danielsen, Herlev Hospital
- Investigators
- Anne K Danielsen, Nurse, MaClN, Principal investigator, Herlev University Hospital, Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154725
- Sponsor's protocol ID
- AKD01
- Status last verified
- Dec 2012
- First submitted
- 30 Jun 2010
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Danielsen AK, Rosenberg J. Patient education after stoma creation may reduce health-care costs. Dan Med J. 2014 Apr;61(4):A4659.
PubMed 24814582Danielsen AK, Rosenberg J. Health related quality of life may increase when patients with a stoma attend patient education--a case-control study. PLoS One. 2014 Mar 7;9(3):e90354. doi: 10.1371/journal.pone.0090354. eCollection 2014.
PubMed 24609004
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patient Education and Rehabilitational Interventions on Health Related Quality of Life of Patients With Permanent Stomas Regardless of Cause
- ClinicalTrials.gov ID
- NCT01154725
- Acronym / sponsor ID
- AKD01
- Conditions
- Colostomy
- Keywords
- Patient education, Health-Related Quality of Life, patients with stomas, stomatherapy, health economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 1 Jul 2010 (estimated)
- 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.
The purpose of the experiment is to study the effect it has on patients' quality of life if they go through a structured process marked by intensified and specialized effort by ostomy nurse. This includes close monitoring during hospitalization, telephone contact and guidance following discharge and participation in a group based patient school up to 4 months after discharge .
At the same time the study also examines what the economic effect of following the intervention will have.
Detailed description
Construction of an ostomy is a radical treatment with permanent physical signs of body alteration. It leads to loss of a central and very personal bodily function (excretion of faeces through the rectum) and there is a significant change in personal hygiene.
Having a colostomy is not a uniform state but is characterized by many different factors: Several types of ostomy, several underlying causes that lead to stoma creation such as cancer, several individual psychosocial profile, which naturally affect individuals differently. Patients are forced to living with a changed body image, a change in daily routines, and for some there will also be changes in lifestyle, social standing and their sexuality will be affected. At the same time patients experience a break when they are discharged from the hospital, and they may lack the practical and emotional support.
The training and education of patients is increasingly being carried out by stoma nurses both in Denmark and internationally. The primary role is to inform and prepare patients before surgery and to keep the contact with patients after surgery to ensure the fulfillment of the patient´s independent and meaningful life after ostomy construction. It is assumed that ostomy nurse's intervention and involvement are important for the patient's quality of life, but there are no studies that uniquely identifies the type of education that has the greatest effect, which applies both to content and methods.
Quality of life measurement in health care is a merging method to ensure the patient´s perspective on health treatments.It is greatly needed to test the efficacy of nursing interventions on patients' quality of life. Pressure on health services increase which makes it imperative also to include analysis and calculation of economic effect of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Habitual stoma care | Other | Behavioral: habitual patient educationhabitual patient education |
| Patient education and rehabilitation | Experimental | Behavioral: Patient education and rehabilitationpatient education and rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with permanent or temporary stomas regardless of cause that are expected to be able to cooperate in filling out questionnaires and who will participate in the planned interventions.
Key exclusion criteria (1 listed)
- Patients that post-operatively are not able to cooperate and participate in the planned interventions.
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 |
|---|---|---|
| Patient education and rehabilitationAlso: health related quality of life, patient education, stoma care, stomatherapyPatients in the experimental group will receive specialized and optimized care by stoma care nurses. This includes one-on-one guiding during the hospitalization, guidance by telephone after discharge and participation in patient education 3 times after discharge. | Behavioural | Patient education and rehabilitation |
| habitual patient educationhabitual patient education | Behavioural | Habitual stoma care |
Primary outcome
Ostomy Adjustment Scale measurement of quality of life
Time frame: 6 months (+/- 2 weeks) postoperatively
the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.
4 secondary outcomes
Economic effect
Time frame: 6 months after discharge
Ostomy Adjustment Scale and SF-36 measurement of quality of life
Time frame: 3 months (+/-2 weeks) postoperatively
Ostomy Adjustment Scale and SF-36 measurement of quality of life
Time frame: 3-7 days postoperatively before discharge
SF-36 measurement of quality of life
Time frame: 6 months (+/- 2 weeks) postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
- Derived from this study: PubMed 24814582Danielsen AK, Rosenberg J. Patient education after stoma creation may reduce health-care costs. Dan Med J. 2014 Apr;61(4):A4659.
- Derived from this study: PubMed 24609004Danielsen AK, Rosenberg J. Health related quality of life may increase when patients with a stoma attend patient education--a case-control study. PLoS One. 2014 Mar 7;9(3):e90354. doi: 10.1371/journal.pone.0090354. eCollection 2014.
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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.
Anne K Danielsen, Nurse, MaClN principal investigator
Herlev University Hospital, Department of Gastroenterology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education and rehabilitation and habitual patient education in people with Colostomy, run by Herlev Hospital at 2 sites in Denmark.
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 1 inclusion and 1 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 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Ostomy Adjustment Scale measurement of quality of life (time frame: 6 months (+/- 2 weeks) postoperatively). 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 NCT01154725, which also lists 2 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 12 Dec 2012.