- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04008862
Partnership-based Nursing Practice for Lung Patients and Their Families
Characteristics and Effectiveness of a Partnership-based Nursing Practice for Patients With Chronic Lung Diseases and Their Families
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ísland
-
Reykjavík, Ísland, Iceland, 1071
- Landspitali National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical ICD 10 diagnosis of J40 to J44 and J96
- Currently receiving the partnership-based nursing care
Exclusion Criteria:
• Not speaking Icelandic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Partnership-based care
Each patient will serve as his/her own control
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18 months
|
Hospital Admissions
Time Frame: 18 months
|
Numerical scale with frequency from 0 to unknown number
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of hospital stay
Time Frame: 18 months
|
Numerical scale fwith numbers from 0 to unknown number
|
18 months
|
Hospital Anxiety and Depression Scale
Time Frame: 18 months
|
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.
|
18 months
|
Capacity to use inhalers
Time Frame: 18 months
|
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.
|
18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COPD Assessment Test (CAT)
Time Frame: 18 months
|
8 items Likert scale (0-5) range from 0 to 40 higher scores indicate lower HRQL.
|
18 months
|
Modified British Medical Research Council Dyspnea Scale (mMRC)
Time Frame: 18 months
|
It is a one item 5-point scale (0-4) based on degrees of various physical activities that precipitate dyspnea.
Less dyspnea is indicated by a lower score.
|
18 months
|
Illness Intrusiveness Rating Scale
Time Frame: 18 months
|
IIRS is a 13-item self-reported questionnaire with three subscales, relationships and personal development (passive recreation, family relations, other social relations, self-expression, religious expression and community and civic involvement), intimacy (relationship with your spouse, and sex life) and instrumental (health, work, active recreation and financial situation).
One item, diet, is not linked to any of the subscales.
A total score is calculated by summing the ratings of all of the items (13-91) and a mean is calculated for each subscale (1-7).
Higher score indicates worse outcome.
|
18 months
|
Sense of Security in Care -Patients' Evaluation (SEC-P)
Time Frame: 18 months
|
Items are scored on a six point Likert scale with means calculated for the total scale as well as the 3 subscales: Care (8 item, range 8 to 48), Identity (4 item, range 4 to 32) and Mastery (3 item, range 3 to 24).
Higher scores indicate a better outcome.
Psychometric properties will be tested in the research.
|
18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Helga Jónsdóttir, Landspitali. National Hospital of Iceland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSH-19-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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