- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02992431
Participatory Patient Care Planning in Primary Care (4PHC)
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.
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Siilinjärvi, Finnland, 71800
- Siilinjärvi Health Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: Usual care
Usual care including standard disease specific follow-up with visit to general practitioner.
|
Usual care including standard disease specific follow-up with visit to general practitioner.
|
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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
15D
Zeitfenster: one year
|
Health related quality of life
|
one year
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
WPAI
Zeitfenster: one year
|
Work Productivity and Activity Impairment Questionnaire
|
one year
|
PAM
Zeitfenster: one year
|
Patient Activation Measurement
|
one year
|
HbA1C
Zeitfenster: one year
|
B -Hemoglobin-A1c
|
one year
|
LDL
Zeitfenster: one year
|
plasma LDL cholesterol
|
one year
|
blood pressure
Zeitfenster: one year
|
blood pressure
|
one year
|
BMI
Zeitfenster: one year
|
body mass index
|
one year
|
waist measure
Zeitfenster: one year
|
waist measure
|
one year
|
visits to nurse
Zeitfenster: one year
|
number of visits to nurse
|
one year
|
visits to physician
Zeitfenster: one year
|
number of visits to physician
|
one year
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Pekka T Mäntyselkä, Professor, University of Eastern Finland
- Hauptermittler: Nina M Tusa, MD, University of Eastern Finland
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 749-1-2017
Plan für individuelle Teilnehmerdaten (IPD)
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