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The Effects of Health Coaching for Frequent Attenders (HCFA)

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ClinicalTrials.gov Identifier: NCT04134858
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oulu

Tracking Information
First Submitted Date  ICMJE September 16, 2019
First Posted Date  ICMJE October 22, 2019
Last Update Posted Date October 22, 2019
Actual Study Start Date  ICMJE October 1, 2014
Actual Primary Completion Date February 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
  • The health-related quality of life [ Time Frame: 12 months ]
    The health-related quality of life was measured using the validated Finnish version of the RAND 36-Item Health Survey 1.0 (RAND-36). The 36-item self-report instrument consists of eight separate scales of quality of life: (1) physical functioning (10 items), (2) physical role functioning (four items), (3) emotional role functioning (three items), (4) social role functioning (two items), (5) bodily pain (two items), (6) mental health (five items), (7) energy (four items) and (8) general health (five items). The scores were calculated in a two-step process using the instructions provided by Ware et al. (1994) in the user´s manual. First, all items were scored on a scale from 0 to 100. A higher score defines a better health or function. Second, items in the same scale were averaged together to create the eight scale scores. Scale scores represented the average for all items in the scale.
  • Adherence to health regimens [ Time Frame: 12 months ]
    Adherence was measured using the Adherence of People with Chronic Disease Instrument (ACDI) (Kyngäs, 1999), a 38-item self-report instrument that has been used to measure adherence to health regimens among people with chronic disease
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
Lifestyle factors [ Time Frame: 12 months ]
The secondary outcomes were lifestyle factors. The baseline and follow-up questionnaires gathered data on the frequent attenders' alcohol consumption, smoking behaviour, and physical activity. They were based on a customized variant of the national FINRISK 2012 questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 21, 2019)
  • The clinical health outcomes: Weight [ Time Frame: 12 months ]
    Weight in kilograms (kg)
  • The clinical health outcomes: Height [ Time Frame: 12 months ]
    Height in meters (m)
  • The clinical health outcomes: Body mass index (BMI) [ Time Frame: 12 months ]
    Weight and height will be combined to report BMI in kg/m^2
  • The clinical health outcomes: Blood pressure [ Time Frame: 12 months ]
    Blood pressure were measured using systolic and diastolic blood pressure in mmHg.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effects of Health Coaching for Frequent Attenders
Official Title  ICMJE The Effectiveness of Health Coaching for Frequent Attenders in the Primary Healthcare
Brief Summary The purpose of the study was to describe and evaluate the effectiveness of health coaching on health-related quality of life, adherence to health regimens, clinical health outcomes and lifestyle factors among frequent attenders in primary healthcare.
Detailed Description The quasi-experimental research method evaluated the effectiveness of health coaching among frequent attenders in primary healthcare. The experimental group received the health coaching and the control group received the usual care. The data were collected with pre- and posttest 12-month follow-up via a questionnaire of FINRISKI2012, RAND-36 and ACDI and clinical health outcomes measured by health-coaching nurses. The data were analyzed by statistical methods.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The experimental and control group
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Health Behavior
Intervention  ICMJE Other: The nurse-led health coaching program
The intervention was based on the customized nurse-led health-coaching program. The program consisted of an individual health-coaching nurse, health-coaching sessions and a written action plan according to each participant´s individual needs.
Study Arms  ICMJE
  • Experimental: The health coaching group
    The experimental group (n = 52) consisted of frequent attenders who had chosen the health-coaching program. The intervention was based on the customized nurse-led health-coaching program. The program consisted of an individual health-coaching nurse, health-coaching sessions and a written action plan according to each participant´s individual needs.
    Intervention: Other: The nurse-led health coaching program
  • No Intervention: The control group
    The control group consisted of 58 frequent attenders. They, along with the experimental group, received the usual care regarding their health problems from the physicians and nurses at the primary healthcare centres if they needed it. The usual care for frequent attenders included assessment for the need of treatment, physical examination, problem assessment, laboratory and X-ray tests, medical advice and patient support and education during their visits.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2019)
110
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date February 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who had face-to-face visits to the physicians in the local primary healthcare centre at least seven times during a 12-month period
  • Aged 18 years or older
  • Able to read and understand Finnish

Exclusion Criteria:

  • Patients´ visits due to pregnancy or delivery
  • Patients´ visits due to serial treatment for the same disease
  • An inability to give informed consent
  • Involving in another study intervention at the same time
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04134858
Other Study ID Numbers  ICMJE Uoulu2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Oulu
Study Sponsor  ICMJE University of Oulu
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Maria Kääriäinen, Professor University of Oulu
PRS Account University of Oulu
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP