Person-centred Care at Distance (PROTECT)
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|ClinicalTrials.gov Identifier: NCT03183817|
Recruitment Status : Unknown
Verified February 2020 by Göteborg University.
Recruitment status was: Active, not recruiting
First Posted : June 12, 2017
Last Update Posted : February 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Chronic Obstructive Pulmonary Disease||Behavioral: Person-centred care at distance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Person-centred Care at Distance for Persons With Chronic Heart Failure (CHF) and/or Chronic Obstructive Pulmonary Disease (COPD)|
|Actual Study Start Date :||August 17, 2017|
|Actual Primary Completion Date :||February 12, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Person-centred care at distance
Person-centred care at distance through an eHealth platform, used both by professionals, patients and relatives
Behavioral: Person-centred care at distance
Person-centred care at distance through an eHealth platform
No Intervention: Usual Care
- Composite score of changes in general self-efficacy [ Time Frame: baseline, 3, 6, 12, 24 months ]
The primary efficacy endpoint is a composite score of changes in general self-efficacy 18 based on the General Self-Efficacy Scale (GSE), hospitalization and death. The rationale for such an endpoint is the value of combining patient experience and clinical outcomes.
A patient is classified as improved, deteriorated or unchanged:
A patient is classified as deteriorated if any of the following occurred:
· at 6 months, self-efficacy has decreased by > 5 units (the minimal change of clinical significance) or has been admitted to hospital for unscheduled reasons or died.
A patient is classified as improved if:
- self-efficacy has increased by > 5 units and has not been hospitalized.
Those who have neither deteriorated nor improved are considered unchanged.
- Number of admissions [ Time Frame: 3, 6, 12, 24 months ]Number of admissions
- General self-efficacy scale [ Time Frame: 3,6,12,24 months ]Questionnaire
- Health care utilization [ Time Frame: 3,6,12,24 months ]number of admissions and unscheduled outpatient visits due to unplanned visits to hospital and/or primary care centre due to symptoms of COPD and CHF
- Incremental cost-utility ratios [ Time Frame: 3,6,12, 24 months ]Incremental cost-utility ratios
- Health-related quality of life (EQ-5D) [ Time Frame: 3,6,12,24 months ]Questionnaire
- Hospital anxiety and depression scale (HADS) [ Time Frame: 3,6,12,24 months ]Questionnaire
- Shortness of breath in heart failure (SOB-HF) [ Time Frame: 3,6,12,24 months ]Questionnaire
- COPD Assessment Test (CAT) [ Time Frame: 3,6,12,24 months ]Questionnaire
- The MRC breathlessness scale [ Time Frame: 3,6,12,24 months ]Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183817
|Primary health care|
|Principal Investigator:||Inger Ekman, Professor||Institute of health and care sciences, Centre for person-centred care (GPCC)|