Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04134858
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2019-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Health Coaching for Frequent Attenders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The experimental and control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2019-09-16', 'studyFirstSubmitQcDate': '2019-10-21', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The clinical health outcomes: Weight', 'timeFrame': '12 months', 'description': 'Weight in kilograms (kg)'}, {'measure': 'The clinical health outcomes: Height', 'timeFrame': '12 months', 'description': 'Height in meters (m)'}, {'measure': 'The clinical health outcomes: Body mass index (BMI)', 'timeFrame': '12 months', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'The clinical health outcomes: Blood pressure', 'timeFrame': '12 months', 'description': 'Blood pressure were measured using systolic and diastolic blood pressure in mmHg.'}], 'primaryOutcomes': [{'measure': 'The health-related quality of life', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Adherence to health regimens', 'timeFrame': '12 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Lifestyle factors', 'timeFrame': '12 months', 'description': "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"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coaching', 'primary health care'], 'conditions': ['Health Behavior']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Aged 18 years or older\n* Able to read and understand Finnish\n\nExclusion Criteria:\n\n* Patients´ visits due to pregnancy or delivery\n* Patients´ visits due to serial treatment for the same disease\n* An inability to give informed consent\n* Involving in another study intervention at the same time'}, 'identificationModule': {'nctId': 'NCT04134858', 'acronym': 'HCFA', 'briefTitle': 'The Effects of Health Coaching for Frequent Attenders', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'The Effectiveness of Health Coaching for Frequent Attenders in the Primary Healthcare', 'orgStudyIdInfo': {'id': 'Uoulu2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The health coaching group', 'description': '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.', 'interventionNames': ['Other: The nurse-led health coaching program']}, {'type': 'NO_INTERVENTION', 'label': 'The control group', 'description': '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.'}], 'interventions': [{'name': 'The nurse-led health coaching program', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['The health coaching group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Maria Kääriäinen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Oulu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}