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Person-centred Care at Distance (PROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
The goal of the research project PROTECT is to translate the Person-Centred Care (PCC) principles into an eHealth (the use of information and communication technologies for health) context. A developed PCC eHealth platform will be used as a tool to identify patients´ resources to enhance coping and living with their chronic illness by means of a dialog and partnership with staff and relatives. The PCC eHealth platform will not replace, but instead be used as add on treatment to usual care (guideline directed care).

Condition or disease Intervention/treatment Phase
Heart Failure Chronic Obstructive Pulmonary Disease Behavioral: Person-centred care at distance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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
Evidence-based care

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Number of admissions [ Time Frame: 3, 6, 12, 24 months ]
    Number of admissions

  2. General self-efficacy scale [ Time Frame: 3,6,12,24 months ]

  3. 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

  4. Incremental cost-utility ratios [ Time Frame: 3,6,12, 24 months ]
    Incremental cost-utility ratios

  5. Health-related quality of life (EQ-5D) [ Time Frame: 3,6,12,24 months ]

  6. Hospital anxiety and depression scale (HADS) [ Time Frame: 3,6,12,24 months ]

  7. Shortness of breath in heart failure (SOB-HF) [ Time Frame: 3,6,12,24 months ]

  8. COPD Assessment Test (CAT) [ Time Frame: 3,6,12,24 months ]

  9. The MRC breathlessness scale [ Time Frame: 3,6,12,24 months ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • National registration within the Västra Götaland Region (VGR)
  • Men and women listed at a primary care centre in Närhälsan with a history of confirmed diagnosis of COPD and /or CHF
  • Must understand written and spoken Swedish

Exclusion Criteria:

  • Severe impairment that prevents patient from using the eHealth support
  • No registered address
  • Any severe disease with an expected survival < 12 months
  • Cognitive impairment (SPMSQ score >6)
  • Ongoing documented diagnosis of alcohol or drug abuse
  • Other disease that can interfere with follow-up (e.g. severe depression, other severe mental illness)
  • Patient participating in another conflicting randomized study

Information from the National Library of Medicine

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

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Primary health care
Gothenburg, Sweden
Sponsors and Collaborators
Göteborg University
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Principal Investigator: Inger Ekman, Professor Institute of health and care sciences, Centre for person-centred care (GPCC)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03183817    
Other Study ID Numbers: PROTECT
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
Person-centred care
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases