Person-centred Care at Distance

NCT03183817 | Unknown

• 1 other identifier: PROTECT
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure; Chronic Obstructive Pulmonary Disease

Keywords

Person-centred care

Outcome Measures

Primary Outcomes (1)

• Composite score of changes in general self-efficacy

  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.

  baseline, 3, 6, 12, 24 months

Secondary Outcomes (9)

• Number of admissions

  3, 6, 12, 24 months

• General self-efficacy scale

  3,6,12,24 months

• Health care utilization

  3,6,12,24 months

• Incremental cost-utility ratios

  3,6,12, 24 months

• Health-related quality of life (EQ-5D)

  3,6,12,24 months

Study Arms (2)

Person-centred care at distance

EXPERIMENTAL

Person-centred care at distance through an eHealth platform, used both by professionals, patients and relatives

Behavioral: Person-centred care at distance

Usual Care

NO INTERVENTION

Evidence-based care

Interventions

Person-centred care at distance BEHAVIORAL

Person-centred care at distance through an eHealth platform

Person-centred care at distance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Primary health care

Gothenburg, Sweden

Location

Related Publications (5)

• Barenfeld E, Ekman I, Cederberg M, Fors A, Ali L, Gyllensten H. Patient and healthcare professional engagement and time use within a randomised controlled trial: investigating intervention costs associated with remote person-centred care in Sweden. BMJ Open. 2025 Oct 9;15(10):e099034. doi: 10.1136/bmjopen-2025-099034.

  PMID: 41067773 DERIVED

• Harvey BP, Barenfeld E, Fors A, Ekman I, Swedberg K, Gyllensten H. Economic evaluation of a person-centred care intervention with a digital platform and structured telephone support for people with chronic heart failure and/or chronic obstructive pulmonary disease: results from a randomised controlled trial in Sweden. BMJ Open. 2025 Oct 9;15(10):e093083. doi: 10.1136/bmjopen-2024-093083.

  PMID: 41067758 DERIVED

• Ali L, Wallstrom S, Fors A, Barenfeld E, Fredholm E, Fu M, Goudarzi M, Gyllensten H, Lindstrom Kjellberg I, Swedberg K, Vanfleteren LEGW, Ekman I. Effects of Person-Centered Care Using a Digital Platform and Structured Telephone Support for People With Chronic Obstructive Pulmonary Disease and Chronic Heart Failure: Randomized Controlled Trial. J Med Internet Res. 2021 Dec 13;23(12):e26794. doi: 10.2196/26794.

  PMID: 34898447 DERIVED

• Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.

  PMID: 34495549 DERIVED

• Ali L, Wallstrom S, Barenfeld E, Fors A, Fredholm E, Gyllensten H, Swedberg K, Ekman I. Person-centred care by a combined digital platform and structured telephone support for people with chronic obstructive pulmonary disease and/or chronic heart failure: study protocol for the PROTECT randomised controlled trial. BMJ Open. 2020 Jul 19;10(7):e036356. doi: 10.1136/bmjopen-2019-036356.

  PMID: 32690519 DERIVED

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Inger Ekman, Professor

  Institute of health and care sciences, Centre for person-centred care (GPCC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 12, 2017
• Study Start: August 17, 2017
• Primary Completion: February 12, 2020
• Study Completion: June 30, 2021
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)