- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04134858
The Effects of Health Coaching for Frequent Attenders (HCFA)
October 21, 2019 updated by: University of Oulu
The Effectiveness of Health Coaching for Frequent Attenders in the Primary Healthcare
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The clinical health outcomes: Weight
Time Frame: 12 months
|
Weight in kilograms (kg)
|
12 months
|
|
The clinical health outcomes: Height
Time Frame: 12 months
|
Height in meters (m)
|
12 months
|
|
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
|
12 months
|
|
The clinical health outcomes: Blood pressure
Time Frame: 12 months
|
Blood pressure were measured using systolic and diastolic blood pressure in mmHg.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Maria Kääriäinen, Professor, University of Oulu
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
September 16, 2019
First Submitted That Met QC Criteria
October 21, 2019
First Posted (Actual)
October 22, 2019
Study Record Updates
Last Update Posted (Actual)
October 22, 2019
Last Update Submitted That Met QC Criteria
October 21, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Uoulu2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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