Chronic Disease, Lung Diseases, Obstructive, Respiratory Disease
Conditions
Keywords
Quality of life, COPD, Intimacy and sexuality, Communication intervention, Physical activity, Randomized controlled trial
Brief summary
The aim of this study is to assess the effectiveness of a communication intervention about sexuality on quality of life and other outcomes like physical activity, exercise capacity and health status in people with chronic obstructive pulmonary disease (COPD).
Detailed description
Human sexuality is a universal part of living and associated with quality of life and mental and physical health benefits. Improved sexual relationships and sexual activity might also be an intrinsic motivator to stay physically active. However, problems with sexuality and loss of sexual drive are common in older and chronically ill people like persons with chronic obstructive pulmonary disease (COPD). In persons with COPD sexuality is rarely addressed during medical consultations and the topic is not sufficiently researched despite the fact that a thorough assessment of quality of life is incomplete without considering sexuality. Based on this background, the investigators developed an instrument that supports healthcare professionals to start and shape communication about sexuality: COSY. The COSY intervention consists of four tools (communication leaflet for health care professionals, application guidance, pictorial representation of the spectrum of intimacy for health care professionals, patient information booklet) and aims to sensitize persons with COPD with the topic sexuality. The aim of this study is to assess the effectiveness of the COSY communication intervention on quality of life and other outcomes like physical activity, exercise capacity and health status in people with COPD.
Interventions
OTHERCommunication intervention about sexuality in people with COPD
COSY is a communication intervention which consists of one face to face counselling (75 min) and two 30-min telephone call counselling. Patients assigned to the intervention group will get the COSY communication intervention with a special focus on the positive impact of sexuality on wellbeing plus specific motivation for physical activity. Together with the patient, a personalized re-enforcement instrument, the COSY-Compass, is elaborated to set individual goals and motivation for physical activity over the whole intervention period (3 months). Participants will learn to understand the positive effect of regular physical activity on physical, mental, and cognitive wellbeing and a more fulfilling sex life as well as get inspiration about the spectrum and possible expressions and manifestations of caring and intimacy with oneself.
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
Due to the kind of intervention and the organizational structure of the study centre, neither patients nor assessors can be blinded, but data analysts will be blinded to group assignment.
Intervention model description
Participants are randomly assigned to either the control or intervention group.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥60 years * Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC)\<70% predicted, FEV1\<80 % predicted after bronchodilation corresponding to a Global initiative on Obstructive Lung Disease (GOLD) stage II-IV * Knowledge of German language to understand study material and assessments and being able to give informed consent as documented by signature
Exclusion criteria
* Unstable COPD at the time of recruitment, unstable cardiovascular comorbidities, severe depression, or predicted life expectancy of less than one year, as judged by the referring clinician or the intervention physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life in old age (CASP-12) | Change from baseline to 3 months | The CASP is a validated measure developed specifically to assess quality of life in old age by the total score of the CASP-12 (Control, Autonomy, Self-realization and Pleasure) german short-version of the CASP-19 scale; 12 questions; 4-point Likert-type-scale ranging from 1 (never) to 4 (often) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exacerbations of COPD (event based, patient reported) | At 3-months follow-up assessment visit | The event-based definition required an increase in symptoms and an increase in dosage of or new prescription of systemic corticosteroids and/or antibiotics |
| Physical activity (PROactive physical activity in COPD instrument, clinical visit version [C-PPAC]; domains amount and difficulty) | Change from baseline to 3 months, measured during 1 week | The C-PPAC is a validated and reliable hybrid tool combining a short patient-reported outcome questionnaire and two activity monitor variables (assessed by the accelerometer ActiGraph®) to measure physical activity in COPD patients in the two domains amount and difficulty; 12 questions; 5-point Likert-type-scale (item scores 0-4, scale 0-100, higher socres indicating higher amonunt of/less difficulty with physical activity) |
| Functional exercise capacity (1-min Sit-to-Stand [STS] test) | Change from baseline to 3 months | The 1-min STS test assesses the number of repetitions that the patient completes the full sit-to-stand movement from a standard chair (i.e. standing up from a chair and sitting down again) during one minute |
| COPD-specific health-related quality of life (Chronic Respiratory Questionnaires [CRQ] Subscales) | Change from baseline to 3 months | The CRQ is a validated tool to assess COPD-specific health-related quality of life with four domains: Dyspnea, fatigue, emotional function, mastery domain. The total CRQ contains 20 questions responded to on a 7-point Likert-type scale, ranging from 1 to 7 with lower scores indicating worse HRQoL |
| Health status (Feeling Thermometer; FT) | Change from baseline to 3 months | The FT is a visual analogue scale for overall health state ranging from 0 (worst health you can imagine) to 100 (best healthy you can imagine) |
| Symptoms of anxiety and depression (Hospital Anxiety and Depression Scale; HADS) | Change from baseline to 3 months | The HADS assesses symptoms of anxiety and depression and contains 14 questions responded to on a 4-point Likert-type scale ranging from 0 to 3 with higher scores indicating a higher symptom score |
| COPD-specific health status / Symptoms (COPD Assessment Test; CAT) | Change from baseline to 3 months | The CAT measures the impact of COPD on a person's health status, covering the most burdensome symptoms and limitations of COPD; 8 questions; 6-point Likert-type scale (item scores: 0-5, overall score 0-40 with higher score indicating poorer health status) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Experience and feedback with the counselling program of the health professionals | At 3-months follow-up assessment visit | Semi-structured interview, outcomes will be qualitatively assessed (no scale is used) |
| Experience and satisfaction with the counselling program of the participants | At 3-months follow-up assessment visit | Semi-structured interview, outcomes will be qualitatively assessed (no scale is used) |
Countries
Switzerland
Outcome results
None listed