NCT04134858

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

September 16, 2019

Last Update Submit

October 21, 2019

Conditions

Health Behavior

Keywords

coachingprimary health care

Outcome Measures

Primary Outcomes (2)

  • The health-related quality of life

    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

    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 Outcomes (1)

  • Lifestyle factors

    12 months

Other Outcomes (4)

  • The clinical health outcomes: Weight

    12 months

  • The clinical health outcomes: Height

    12 months

  • The clinical health outcomes: Body mass index (BMI)

    12 months

  • +1 more other outcomes

Study Arms (2)

The health coaching group

EXPERIMENTAL

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 control group

NO INTERVENTION

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

The nurse-led health coaching programOTHER

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 health coaching group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Maria Kääriäinen, Professor

    University of Oulu

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The experimental and control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2019

First Posted

October 22, 2019

Study Start

October 1, 2014

Primary Completion

February 1, 2016

Study Completion

December 31, 2016

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share