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The Effects of Health Coaching for Frequent Attenders (HCFA)

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

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.

Condition or disease Intervention/treatment Phase
Health Behavior Other: The nurse-led health coaching program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The experimental and control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Health Coaching for Frequent Attenders in the Primary Healthcare
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : February 1, 2016
Actual Study Completion Date : December 31, 2016

Arm Intervention/treatment
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.
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.

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.



Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. The clinical health outcomes: Weight [ Time Frame: 12 months ]
    Weight in kilograms (kg)

  2. The clinical health outcomes: Height [ Time Frame: 12 months ]
    Height in meters (m)

  3. 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

  4. The clinical health outcomes: Blood pressure [ Time Frame: 12 months ]
    Blood pressure were measured using systolic and diastolic blood pressure in mmHg.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04134858


Sponsors and Collaborators
University of Oulu
Investigators
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Study Director: Maria Kääriäinen, Professor University of Oulu
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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT04134858    
Other Study ID Numbers: Uoulu2014
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
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 University of Oulu:
coaching
primary health care