Partnership-based Nursing Practice for Lung Patients and Their Families

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Characteristics and Effectiveness of a Partnership-based Nursing Practice for Patients With Chronic Lung Diseases and Their Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008862
• Other study ID #: LSH-19-001
• Status: Completed
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2021
• Source: Landspitali University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Clinical ICD 10 diagnosis of J40 to J44 and J96

• Currently receiving the partnership-based nursing care

Exclusion Criteria:

• Not speaking Icelandic

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Obstructive Pulmonary Disease
• Family
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Partnership-based nursing practice
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.

Locations

Country	Name	City	State
Iceland	Landspitali National University Hospital	Reykjavík	Ísland

Sponsors (2)

Lead Sponsor	Collaborator
Helga Jónsdóttir	University of Iceland

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	COPD Assessment Test (CAT)	8 items Likert scale (0-5) range from 0 to 40 higher scores indicate lower HRQL.	18 months
Other	Modified British Medical Research Council Dyspnea Scale (mMRC)	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
Other	Illness Intrusiveness Rating Scale	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
Other	Sense of Security in Care -Patients' Evaluation (SEC-P)	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
Primary	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.	18 months
Primary	Hospital Admissions	Numerical scale with frequency from 0 to unknown number	18 months
Secondary	Length of hospital stay	Numerical scale fwith numbers from 0 to unknown number	18 months
Secondary	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.	18 months
Secondary	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.	18 months