Hypertension4PHCNCT02992431
Participatory Patient Care Planning in Primary Care
A study testing Participatory patient care planning in people with Hypertension and Ischemic Heart Disease, run by Kuopio University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Ischemic Heart Disease, Diabetes Mellitus
- What is being tested?
- Participatory patient care planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2017to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hypertension, ischemic hearth disease or diabetes living in the municipality of Siilinjärvi
Who cannot join
- Permanent bed patient, terminal phase of any serious condition, severe decline in cognition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Participatory Patient Care Planning in Primary Care: Effectiveness and Feasibility in Patients With Hypertension, Ischemic Heart Disease or Diabetes
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.
Read more
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.
- Conditions
- Hypertension, Ischemic Heart Disease, Diabetes Mellitus
- Being tested
- Participatory patient care planning, Usual care
- Keywords
- patient care planning, primary health care, comorbidity
- Medical subject headings
- Hypertension, Myocardial Ischemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory patient care planningBehavioural
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.
Usual careOther
Usual care including standard disease specific follow-up with visit to general practitioner.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Usual care including standard disease specific follow-up with visit to general practitioner. Receives: 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. Receives: Behavioral: Participatory patient care planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
15D
Health related quality of life
Measured: one year
Secondary outcomes (9)
WPAI
Work Productivity and Activity Impairment Questionnaire
Measured: one year
PAM
Patient Activation Measurement
Measured: one year
HbA1C
B -Hemoglobin-A1c
Measured: one year
LDL
plasma LDL cholesterol
Measured: one year
blood pressure
blood pressure
Measured: one year
BMI
body mass index
Measured: one year
waist measure
waist measure
Measured: one year
visits to nurse
number of visits to nurse
Measured: one year
visits to physician
number of visits to physician
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Siilinjärvi Health Center, University of Eastern Finland
- Responsible party
- Principal investigator, Pekka Mäntyselkä, Kuopio University Hospital
- Investigators
- Pekka T Mäntyselkä, Professor, Study chair, University of Eastern FinlandNina M Tusa, MD, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992431
- Sponsor's protocol ID
- 749-1-2017
- Acronym
- 4PHC
- Status last verified
- Mar 2022
- First submitted
- 12 Dec 2016
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 40217248Mikkonen U, Tusa N, Sinikallio S, Kautiainen H, Mantyselka P. A short tool to screen self-care preparedness: cross-sectional study in general practice. Fam Pract. 2024 Dec 2;41(6):970-976. doi: 10.1093/fampra/cmad107.
PubMed 37975623Tusa 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.
PubMed 37455531Tusa 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 34284783Tusa 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participatory Patient Care Planning in Primary Care: Effectiveness and Feasibility in Patients With Hypertension, Ischemic Heart Disease or Diabetes
- ClinicalTrials.gov ID
- NCT02992431
- Acronym / sponsor ID
- 4PHC / 749-1-2017
- Conditions
- Hypertension, Ischemic Heart Disease, Diabetes Mellitus
- Keywords
- patient care planning, primary health care, comorbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Siilinjärvi Health Center, University of Eastern Finland
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual careUsual care including standard disease specific follow-up with visit to general practitioner. |
| Participatory patient care planning | Experimental | Behavioral: Participatory patient care planningIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with hypertension, ischemic hearth disease or diabetes living in the municipality of Siilinjärvi
Key exclusion criteria (1 listed)
- Permanent bed patient, terminal phase of any serious condition, severe decline in cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participatory patient care planningIntervention 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. | Behavioural | Participatory patient care planning |
| Usual careUsual care including standard disease specific follow-up with visit to general practitioner. | Other | Usual care |
Primary outcome
15D
Time frame: one year
Health related quality of life
9 secondary outcomes
WPAI
Time frame: one year
PAM
Time frame: one year
HbA1C
Time frame: one year
LDL
Time frame: one year
blood pressure
Time frame: one year
BMI
Time frame: one year
waist measure
Time frame: one year
visits to nurse
Time frame: one year
visits to physician
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 40217248Tusa 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.
- Derived from this study: PubMed 37975623Mikkonen U, Tusa N, Sinikallio S, Kautiainen H, Mantyselka P. A short tool to screen self-care preparedness: cross-sectional study in general practice. Fam Pract. 2024 Dec 2;41(6):970-976. doi: 10.1093/fampra/cmad107.
- Derived from this study: PubMed 37455531Tusa 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.
- Derived from this study: PubMed 34284783Tusa 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.
- Derived from this study: PubMed 33148185Tusa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pekka T Mäntyselkä, Professor study chair
University of Eastern Finland
Nina M Tusa, MD principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory patient care planning in people with Hypertension and Ischemic Heart Disease, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
15D (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02992431, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.