Chronic Obstructive Pulmonary DiseaseNCT04008862
Partnership-based Nursing Practice for Lung Patients and Their Families
A study testing Partnership-based nursing practice in people with Chronic Obstructive Pulmonary Disease and Family, run by Helga Jónsdóttir at 1 site in Iceland.
Trial summary
This study aims to describe and measure the effectiveness of partnership-based nursing care for people with Chronic Obstructive Pulmonary Disease (COPD) and their families. Investigators hypothesize that an holistic, inclusive -taking account of the challenge of multi-morbidity and the long-term relationship that… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Family, Chronic Disease
- What is being tested?
- Partnership-based nursing practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIceland
- Study dates
- 28 May 2018to 30 Dec 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical ICD 10 diagnosis of J40 to J44 and J96
- Currently receiving the partnership-based nursing care
Who cannot join
- Not speaking Icelandic
Trial locations and contacts
1 site in 1 country.
Iceland1 site
Landspitali National University Hospital
Reykjavik, Ísland, 1071
About this study
Official title: Characteristics and Effectiveness of a Partnership-based Nursing Practice for Patients With Chronic Lung Diseases and Their Families
This study aims to describe and measure the effectiveness of partnership-based nursing care for people with Chronic Obstructive Pulmonary Disease (COPD) and their families. Investigators hypothesize that an holistic, inclusive -taking account of the challenge of multi-morbidity and the long-term relationship that patients with COPD and their families have with the nurses along with the open structure of whatever kind of services is needed in each patient-family case, often in interdisciplinary and inter-institutional collaboration- , is beneficial as regards use of healthcare, health characteristics, HRQL, use of inhaler medications, sense of security in care and illness intrusiveness.
Read the detailed description
Growing number of people with chronic lung diseases, particularly chronic obstructive pulmonary disease (COPD), and the wide ranging burden that the disease induces to individuals, families and societies, has spurred concerted efforts to develop new healthcare for these people. Outpatient clinics are receiving increasing recognition, particularly those managed by nurses. An out-patient nursing clinic based on theoretical premises of partnership as practice has been established at Landspitali University Hospital. Initial research has shown effectiveness of the practice on the use of healthcare, health status, health related quality of life as well as increased capacity of families to live a meaningful life with the disease. There is a need to substantiate knowledge of the effectiveness of the partnership-based practice by focusing on use of healthcare resources, health and the experience of patients and families, as well as developing educational material for nurses.
Investigators hypothesize that the holistic, inclusive -taking account of the challenge of multi-morbidity and the long-term relationship that patients with COPD and their families have with the nurses along with the open structure of whatever kind of services is needed in each patient-family case, often in interdisciplinary and inter-institutional collaboration- , is beneficial as regards use of healthcare, health characteristics, HRQL, use of inhaler medications, sense of security in care and illness intrusiveness. The experience of patients with COPD and their families of living with the disease and receiving the care will substantiate the previously indicated variables. To this study a multi-dimensional approach is needed which includes both a holistic evaluation (qualitatively studying the experience of participants) and which measures variables prevalent in studies on self-management and palliative care (quantitative use of instruments and demographic variables).
- Being tested
- Partnership-based nursing practice
- Keywords
- Chronic Obstructive Pulmonary Disease, Self-management, Palliative care, Family, Chronic Disease, Nursing practice
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partnership-based nursing practiceBehavioural
Provided by clinical nurse specialists (n=2) and specialized nurses (n=3): i) Partnership-based theoretical nursing practice framework: Family involvement, living with symptoms and access to healthcare -primary goal of enhancement of the health experience. Key question: What are your main concerns about the health of the person with the lung disease? Followed by conversations: a) Existence of lung disease and symptoms that the patient has. b) Nature of disease, its management, quitting smoking, use of inhaler medications, utilization of health care, negative feelings and issues. Skills and motivation to undertake activities to maintain and improve well-being, skills in communication with family, relatives and health professionals. ii) Empirical knowledge about the nature of COPD, symptom management and palliative care and the GOLD clinical guidelines. iii) Patients are seen over an undefined time period in the out-patient clinic or at home depending on needs and capabilities.
| Study group | Role | What they receive |
|---|---|---|
| Partnership-based care | Experimental | Each patient will serve as his/her own control Receives: Behavioral: Partnership-based nursing practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life: St. Georges Respiratory Questionnaire 40 item
40 items with Likert-type and dichotomous questions, which are aggregated into a total score and three subscales; symptoms, activity and impacts. Each of the three subscales and the total score is scaled separately in the range 0-100. Higher scores reflect less quality of life. A score change of four units is considered clinically significant.
Measured: 18 months
Hospital Admissions
Numerical scale with frequency from 0 to unknown number
Measured: 18 months
Secondary outcomes (3)
Length of hospital stay
Numerical scale fwith numbers from 0 to unknown number
Measured: 18 months
Hospital Anxiety and Depression Scale
14-item, four-point (0-3) Likert scale with two subscales, anxiety (0-21) and depression (0-21). A mean is calculated for each scale. Higher scores indicates worse condition.
Measured: 18 months
Capacity to use inhalers
Numerical scale 10 item, 4-point Likert type data collection tool. It is has two scales, capacity to inhale medications (5 items) and technical skills to use the inhalers (5 items). Each scale ranges from 0 to 20. A mean is calculated for each score. Higher score indicates better skills in using the inhaler.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start28 May 2018
- Primary completion28 Jul 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Longitudinal design, participants serve as their own control.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helga Jónsdóttir
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iceland
- Responsible party
- Sponsor-investigator, Helga Jónsdóttir, Landspitali University Hospital
- Investigators
- Helga Jónsdóttir, Principal investigator, Landspitali. National Hospital of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008862
- Sponsor's protocol ID
- LSH-19-001
- Status last verified
- Feb 2021
- First submitted
- 27 Jun 2019
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Effectiveness of a Partnership-based Nursing Practice for Patients With Chronic Lung Diseases and Their Families
- ClinicalTrials.gov ID
- NCT04008862
- Acronym / sponsor ID
- LSH-19-001
- Keywords
- Chronic Obstructive Pulmonary Disease, Self-management, Palliative care, Family, Chronic Disease, Nursing practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Helga JónsdóttirUniversity, hospital or other
- Collaborators
- University of Iceland
- Study start
- 28 May 2018 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 5 Jul 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.
This study aims to describe and measure the effectiveness of partnership-based nursing care for people with Chronic Obstructive Pulmonary Disease (COPD) and their families. Investigators hypothesize that an holistic, inclusive -taking account of the challenge of multi-morbidity and the long-term relationship that patients with COPD and their families have with the nurses along with the open structure of whatever kind of services is needed in each patient-family case, often in interdisciplinary and inter-institutional collaboration- , is beneficial as regards use of healthcare, health characteristics, HRQL, use of inhaler medications, sense of security in care and illness intrusiveness.
Detailed description
Growing number of people with chronic lung diseases, particularly chronic obstructive pulmonary disease (COPD), and the wide ranging burden that the disease induces to individuals, families and societies, has spurred concerted efforts to develop new healthcare for these people. Outpatient clinics are receiving increasing recognition, particularly those managed by nurses. An out-patient nursing clinic based on theoretical premises of partnership as practice has been established at Landspitali University Hospital. Initial research has shown effectiveness of the practice on the use of healthcare, health status, health related quality of life as well as increased capacity of families to live a meaningful life with the disease. There is a need to substantiate knowledge of the effectiveness of the partnership-based practice by focusing on use of healthcare resources, health and the experience of patients and families, as well as developing educational material for nurses.
Investigators hypothesize that the holistic, inclusive -taking account of the challenge of multi-morbidity and the long-term relationship that patients with COPD and their families have with the nurses along with the open structure of whatever kind of services is needed in each patient-family case, often in interdisciplinary and inter-institutional collaboration- , is beneficial as regards use of healthcare, health characteristics, HRQL, use of inhaler medications, sense of security in care and illness intrusiveness. The experience of patients with COPD and their families of living with the disease and receiving the care will substantiate the previously indicated variables. To this study a multi-dimensional approach is needed which includes both a holistic evaluation (qualitatively studying the experience of participants) and which measures variables prevalent in studies on self-management and palliative care (quantitative use of instruments and demographic variables).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal design, participants serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Partnership-based care | Experimental | Behavioral: Partnership-based nursing practiceEach patient will serve as his/her own control |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical ICD 10 diagnosis of J40 to J44 and J96
- Currently receiving the partnership-based nursing care
Key exclusion criteria (1 listed)
- Not speaking Icelandic
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 |
|---|---|---|
| Partnership-based nursing practiceProvided by clinical nurse specialists (n=2) and specialized nurses (n=3): i) Partnership-based theoretical nursing practice framework: Family involvement, living with symptoms and access to healthcare -primary goal of enhancement of the health experience. Key question: What are your main concerns about the health of the person with the lung disease? Followed by conversations: a) Existence of lung disease and symptoms that the patient has. b) Nature of disease, its management, quitting smoking, use of inhaler medications, utilization of health care, negative feelings and issues. Skills and motivation to undertake activities to maintain and improve well-being, skills in communication with family, relatives and health professionals. ii) Empirical knowledge about the nature of COPD, symptom management and palliative care and the GOLD clinical guidelines. iii) Patients are seen over an undefined time period in the out-patient clinic or at home depending on needs and capabilities. | Behavioural | Partnership-based care |
Primary outcome
Health Related Quality of Life: St. Georges Respiratory Questionnaire 40 item
Time frame: 18 months
40 items with Likert-type and dichotomous questions, which are aggregated into a total score and three subscales; symptoms, activity and impacts. Each of the three subscales and the total score is scaled separately in the range 0-100. Higher scores reflect less quality of life. A score change of four units is considered clinically significant.
Hospital Admissions
Time frame: 18 months
Numerical scale with frequency from 0 to unknown number
3 secondary outcomes
Length of hospital stay
Time frame: 18 months
Hospital Anxiety and Depression Scale
Time frame: 18 months
Capacity to use inhalers
Time frame: 18 months
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 18 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Helga Jónsdóttir principal investigator
Landspitali. National Hospital of Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partnership-based nursing practice in people with Chronic Obstructive Pulmonary Disease and Family, run by Helga Jónsdóttir at 1 site in Iceland.
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 2 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 18 Feb 2021. 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 Iceland. 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?
Health Related Quality of Life: St. Georges Respiratory Questionnaire 40 item (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2021.