NCT02992431

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

6.9 years

First QC Date

December 12, 2016

Last Update Submit

March 30, 2022

Conditions

Keywords

patient care planningprimary health carecomorbidity

Outcome Measures

Primary Outcomes (1)

  • 15D

    Health related quality of life

    one year

Secondary Outcomes (9)

  • WPAI

    one year

  • PAM

    one year

  • HbA1C

    one year

  • LDL

    one year

  • blood pressure

    one year

  • +4 more secondary outcomes

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Usual care including standard disease specific follow-up with visit to general practitioner.

Other: Usual care

Participatory patient care planning

EXPERIMENTAL

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.

Behavioral: Participatory patient care planning

Interventions

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.

Participatory patient care planning

Usual care including standard disease specific follow-up with visit to general practitioner.

Usual care

Eligibility Criteria

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

You may qualify if:

  • Patients with hypertension, ischemic hearth disease or diabetes living in the municipality of Siilinjärvi

You may not qualify if:

  • Permanent bed patient, terminal phase of any serious condition, severe decline in cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siilinjärvi Health Center

Siilinjärvi, 71800, Finland

Location

Related Publications (4)

  • Tusa N, Mikkonen U, Kautiainen H, Mantyselka P. Participatory care plan for primary care patients with long-term diseases: results after a 36-month follow-up of a randomized controlled trial. BMC Health Serv Res. 2025 Apr 12;25(1):536. doi: 10.1186/s12913-025-12660-6.

  • Tusa N, Kautiainen H, Elfving P, Sinikallio S, Mantyselka P. Depressive symptoms decrease health-related quality of life of patients with coronary artery disease and diabetes: a 12-month follow up study in primary care. Scand J Prim Health Care. 2023 Sep;41(3):276-286. doi: 10.1080/02813432.2023.2233995. Epub 2023 Jul 16.

  • Tusa N, Kautiainen H, Elfving P, Sinikallio S, Mantyselka P. Randomized controlled study of the impact of a participatory patient care plan among primary care patients with common chronic diseases: a one-year follow-up study. BMC Health Serv Res. 2021 Jul 20;21(1):715. doi: 10.1186/s12913-021-06716-6.

  • Tusa N, Kautiainen H, Elfving P, Sinikallio S, Mantyselka P. Relationship between patient activation measurement and self-rated health in patients with chronic diseases. BMC Fam Pract. 2020 Nov 4;21(1):225. doi: 10.1186/s12875-020-01301-y.

MeSH Terms

Conditions

HypertensionMyocardial IschemiaDiabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeart DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Pekka T Mäntyselkä, Professor

    University of Eastern Finland

    STUDY CHAIR
  • Nina M Tusa, MD

    University of Eastern Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 14, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations