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Trial record 16 of 228 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Person-centred eHealth for Treatment and Rehabilitation of Severe Stress and Burnout Syndrome (PROMISE)

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ClinicalTrials.gov Identifier: NCT03404583
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
The goal of the research project PROMISE 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 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
Mental Health Behavioral: Person-centred care at distance through an eHealth platform Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Person-centred eHealth for Treatment and Rehabilitation of Severe Stress and Burnout Syndrome - a Randomized Controlled Trial in Primary Health Care
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Person-centred care at distance
Person-centred care at distance through an eHealth platform
Behavioral: Person-centred care at distance through an eHealth platform
Person-centred care at distance through an eHealth platform, used by professionals, patients and relatives

No Intervention: Usual Care
Evidence-based care



Primary Outcome Measures :
  1. Composite score of changes [ Time Frame: baseline, 3, 6, 12, 18, 24 months ]

    A patient is classified as improved, deteriorated or unchanged:

    A patient is classified as improved if:

    at 6 months reduced sick leave and increased general self-efficacy by ≥ 5 units

    A patient is classified as deteriorated if:

    at 6 months increased sick leave or (if on full-time sick leave at inclusion reduced general self-efficacy by ≥ 5 units)

    Those who have neither deteriorated nor improved are considered unchanged



Secondary Outcome Measures :
  1. Sick leave [ Time Frame: baseline, 3, 6, 12, 18, 24 months ]
    Grade of sick leave

  2. General self-efficacy scale [ Time Frame: baseline, 3, 6, 12, 18, 24 months ]
    Questionnaire

  3. Health-related quality of Life (EQ-5D) [ Time Frame: baseline, 3, 6, 12, 18, 24 months ]
    Questionnaire

  4. Hospital anxiety and depression scale (HADS) [ Time Frame: baseline, 3, 6, 12, 18, 24 months ]
    Questionnaire

  5. Symptom burden (Shirom-Melamed Burnout Measure) [ Time Frame: baseline, 3, 6, 12, 18, 24 months ]
    Questionnaire

  6. Perceived stress scale (PSS) [ Time Frame: baseline, 3, 6, 12, 18, 24 months ]
    Questionnaire

  7. Self-rated burnout syndrome (s-UMS) [ Time Frame: baseline, 3, 6, 12, 18, 24 months ]
    Questionnaire

  8. Health care utilization [ Time Frame: 3, 6, 12, 18, 24 months ]
    Health care utilization

  9. Incremental cost-utility ratios [ Time Frame: 3, 6, 12, 18, 24 months ]
    Incremental cost-utility ratios

  10. Multidimensional fatigue symptom inventory (MFI-20) [ Time Frame: 3, 6, 12, 18, 24 months ]
    Questionnaire

  11. Sheehan disability scale (SDS) [ Time Frame: 3, 6, 12, 18, 24 months ]
    Questionnaire

  12. Self-efficacy (self-care) [ Time Frame: 3, 6, 12, 18, 24 months ]
    Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• Men and women fulfilling criteria for any of the following diagnoses: stress, depression or anxiety and on sick leave since ≤30 days

• Paid professional work, at least part time, during the last 9 months and willing to participate

Exclusion Criteria:

  • Sick leave >14 days for any of the above mentioned diagnoses during the last 3 months.
  • Severe impairment that prevents patient from using the eHealth support
  • No registered address
  • Not willing to participate
  • Any severe disease with an expected survival <12 months
  • Cognitive impairment
  • Ongoing documented diagnosis of alcohol or drug abuse
  • Other severe disease that can interfere with follow-up or if the intervention is assessed as a burden
  • 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): NCT03404583


Contacts
Contact: Andreas Fors, PhD +46709115931 andreas.fors@gu.se
Contact: Lilas Ali, PhD lilas.ali@gu.se

Locations
Sweden
Primary health care Recruiting
Gothenburg, Sweden
Contact: Andreas Fors, PhD    0709-115931    andreas.fors@gu.se   
Sponsors and Collaborators
Göteborg University
Investigators
Principal Investigator: Andreas Fors, PhD Institute of health and care sciences, Centre for person-centred care (GPCC)

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03404583     History of Changes
Other Study ID Numbers: PROMISE
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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