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Status unknownNCT029924314PHCUpdated Mar 31, 2022

Participatory Patient Care Planning in Primary Care

An interventional study of Participatory patient care planning and Usual care in Hypertension, Ischemic Heart Disease and Diabetes Mellitus, sponsored by Kuopio University Hospital. Status unknown at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Kuopio University Hospital · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Hypertension
  • Ischemic Heart Disease
  • Diabetes Mellitus

Keywords

  • patient care planning
  • primary health care
  • comorbidity
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 600 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Kuopio University Hospital is the lead sponsor of 132 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Permanent bed patient, terminal phase of any serious condition, severe decline in cognition
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (actual)

Study arms

  • Active comparator
    Usual care

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

    Other: Usual care

  • Experimental
    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.

    Behavioral: Participatory patient care planning

Interventions

  • BehavioralParticipatory 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.

  • OtherUsual care

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

06

What researchers measure

Primary outcomes

  1. 15D

    Health related quality of life

    Time frame: one year

Secondary outcomes

  1. WPAI

    Work Productivity and Activity Impairment Questionnaire

    Time frame: one year

  2. PAM

    Patient Activation Measurement

    Time frame: one year

  3. HbA1C

    B -Hemoglobin-A1c

    Time frame: one year

  4. LDL

    plasma LDL cholesterol

    Time frame: one year

  5. blood pressure

    blood pressure

    Time frame: one year

  6. BMI

    body mass index

    Time frame: one year

  7. waist measure

    waist measure

    Time frame: one year

  8. visits to nurse

    number of visits to nurse

    Time frame: one year

  9. visits to physician

    number of visits to physician

    Time frame: one year

07

Study locations

1 site
  • Siilinjärvi Health Center
    Siilinjärvi, 71800, Finland
08

References and documents

Publications

  • 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. PubMed 34284783 ↗
  • 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. PubMed 33148185 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02992431
Lead sponsor
Kuopio University Hospital
Collaborators
Siilinjärvi Health Center, University of Eastern Finland
Responsible party
Pekka Mäntyselkä (Professor, Kuopio University Hospital) — Principal investigator
First posted
Dec 14, 2016
Start date
Jan 2017
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Mar 31, 2022

Study contacts

Pekka T Mäntyselkä, Professor
study chair · University of Eastern Finland
Nina M Tusa, MD
principal investigator · University of Eastern Finland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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