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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02992431
Other study ID # 749-1-2017
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date December 2023

Study information

Verified date March 2022
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the aging population, the prevalence of chronic diseases and multimorbidity has become common. Therefore, the planning and coordination of care have become more important. However, it is not known what kind of treatment plan should be and what kind of patients would benefit most of it. This research focuses on the participatory patient care planning in primary health care. In general, the participatory patient care planning (PPCP) aims to engage patients in self-care, to improve the collaboration between patients and professionals and to improve the use of resources. The present study investigates the feasibility and effectiveness of the PPCP. The specific research questions of the present study are: Does the PPCP have an impact on the patient's quality of life? Does the PPCP improve the quality of care in management of chronic diseases? Does the PPCP improve patient's commitment with self-care? Does the PPCP impact on the use of health care services? The data consists of people aged at least 18 years living in the municipality of Siilinjärvi with diabetes, coronary heart disease or hypertension and who are recorded in in Siilinjärvi Health Care Center electronic patient record. The participating patients are recruited from those who contacts SiiIinjärvi Health Care Center in order to have a follow-up visit because of the treatment of their disease. This study aims to recruit 700 patients. The participants are allocated into the intervention group and into the control group receiving usual care. Intervention consists of the PPCP. This includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP. The main out-come measures are the quality of health related life measured with the 15D; the level of patient's activity in self-care with the Patient Activation Measurement (PAM); life satisfaction, self-rated health, a reduction in productivity with the Work Productivity and Activity Impairment Questionnaire (WPAI: GH), and the disease specific measures (blood pressure, HbA1C, LDL-cholesterol, body mass index and waist measurement). In addition, pain intensity and interference (NRS 0-10), mood (BDI-21), the number of visits and phone calls and referrals are measured.


Description:

This research focuses on the participatory patient care planning in primary health care. In general, the participatory patient care planning (PPCP) aims to engage patients in self-care, to improve the collaboration between patients and professionals and to improve the use of resources. The present study investigates the feasibility and effectiveness of the PPCP. The specific research questions of the present study are: Does the PPCP have an impact on the patient's quality of life? Does the PPCP improve the quality of care in management of chronic diseases? Does the PPCP improve patient's commitment with self-care? Does the PPCP impact on the use of health care services? The data consists of people aged at least 18 years living in the municipality of Siilinjärvi with diabetes, coronary heart disease or hypertension and who are recorded in in Siilinjärvi Health Care Center electronic patient record. The participating patients are recruited from those who contacts SiiIinjärvi Health Care Center in order to have a follow-up visit because of the treatment of their disease. This study aims to recruit 700 patients. The participants are allocated into the intervention group and into the control group receiving usual care. Intervention consists of the PPCP. This includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP. The main out-come measures are the quality of health related life measured with the 15D; the level of patient's activity in self-care with the Patient Activation Measurement (PAM); life satisfaction, self-rated health, a reduction in productivity with the Work Productivity and Activity Impairment Questionnaire (WPAI: GH), and the disease specific measures (blood pressure, HbA1C, LDL-cholesterol, body mass index and waist measurement). In addition, pain intensity and interference (NRS 0-10), mood (BDI-21), the number of visits and phone calls and referrals are measured.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with hypertension, ischemic hearth disease or diabetes living in the municipality of Siilinjärvi Exclusion Criteria: - Permanent bed patient, terminal phase of any serious condition, severe decline in cognition

Study Design


Intervention

Behavioral:
Participatory patient care planning
Intervention includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP.
Other:
Usual care
Usual care including standard disease specific follow-up with visit to general practitioner.

Locations

Country Name City State
Finland Siilinjärvi Health Center Siilinjärvi

Sponsors (3)

Lead Sponsor Collaborator
Kuopio University Hospital Siilinjärvi Health Center, University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 15D Health related quality of life one year
Secondary WPAI Work Productivity and Activity Impairment Questionnaire one year
Secondary PAM Patient Activation Measurement one year
Secondary HbA1C B -Hemoglobin-A1c one year
Secondary LDL plasma LDL cholesterol one year
Secondary blood pressure blood pressure one year
Secondary BMI body mass index one year
Secondary waist measure waist measure one year
Secondary visits to nurse number of visits to nurse one year
Secondary visits to physician number of visits to physician one year
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