Ignite Creation Date:
2024-05-06 @ 10:10 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03183817
Status:
UNKNOWN
Last Update Posted:
2020-02-25
First Post:
2017-06-07
Brief Title:
Person-centred Care at Distance
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
Person-centred Care at Distance for Persons With Chronic Heart Failure CHF andor Chronic Obstructive Pulmonary Disease COPD
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECT
Brief Summary:
The goal of the research project PROTECT is to translate the Person-Centred Care PCC principles into an eHealth the use of information and communication technologies for health context A developed PCC eHealth platform will be used as a tool to identify patients resources to enhance coping and living with their chronic illness by means of a dialog and partnership with staff and relatives The PCC eHealth platform will not replace but instead be used as add on treatment to usual care guideline directed care
Detailed Description:
A pilot study and collaboration between patients relatives and professionals in the research program has clarified the need to develop a PCC eHealth platform Previous research has shown that eHealth support where the users are not involved in the process has a low impact and has highlighted several limitations with respect to patients participation in the design process its anchorage in the home and local environment and opportunities for communication rather than information Therefore this study has a participatory design which assumes that all users patients relatives and health care professionals are involved in the study design which facilitates implementation An end-user perspective as a starting point increases the chances that users adapt a positive attitude towards the new system Person-centred care combined with an eHealth support along the chain of health care showed a 4-fold chance of improved self-efficacy in combination with return to work or prior activity level after an event of acute coronary syndrome
PCC can be delivered at distance and make health care more effective above and beyond usual care Inclusion of the principles of PCC in an eHealth support for patients with chronic heart failure CHF andor chronic obstructive pulmonary disease COPD will reduce the need for medical care primary care and hospital admission amongst these patients by improving self-management self-efficacy and collaboration in the process of care
The aim of this project is to implement and evaluate the PCC approach at distance to patients with CHF andor COPD and their informal care givers to live better and cope more effectively with the disease burden associated with CHF andor COPD In the PCC approach the aims capabilities and needs of each patient will be the starting point Self-care strategies will be reinforced and empowered
This study is a randomized open parallel group intervention study where patients are eligible when they are hospitalized due to worsening CHF andor COPD They will be asked before discharge about participation
Patients admitted to hospital for worsening CHF andor COPD will be recruited by the research nurses employed in this project from Emergency or on the ward once their condition has stabilized sufficiently
Patients will be screened against inclusion and exclusion criteria for eligibility to participate in the study Written informed consent will be obtained Patients will be randomized into either the control or the intervention arm 11 The control group will receive usual care The intervention group will receive usual care plus a PCC nurse-led intervention Randomization will be done through computer generated lists and stored in sealed envelopes
Patients listed in Närhälsan with a confirmed diagnosis of CHF andor COPD will be screened and sent an informing letter about the study from the chief at each centre Specially trained registered nurses RNs will then screen patients against study inclusion and exclusion criteria and by phone contact eligible patients and inform the patient about the aims of the study and ask if they are interested to participate If the patient wants to participate a consent form is sent to the patient and then returned to the RN Then the randomization procedure is performed which is based on a computer-generated list and the patient will be informed about the outcome by phone Patients randomized to the intervention group will need a computer smart phone or iPad to participate in the study Patients who want will have the possibility to be provided an iPad for the duration of their participation in the programme
Two dedicated full-time Registered Nurses RN follow the procedures closely A monitor controls the protocol adherence All case record forms questionnaires and referrals will be constructed for intervention and usual care groups
Patients listed at a primary care centre in Närhälsan with CHF andor COPD will be randomized to usual care control or PCC intervention after informed and written consent Follow-up questionnaires on general self-efficacy cardiac self-efficacy quality of life anxiety and depression will be sent out to all patients in both groups after 3612 and 24 months after randomization
Patients randomized to usual care will be managed by regular evidence-based treatment and care as outlined in treatment guidelines and followed as usual at their local primary care centre
Patients will be called by a dedicated RN who has received special training in PCC communication at distance the eHealth platform CHF and COPD for an initial person-centred dialogue by phone Based on the patient narrative patients goals resources and needs are identified The patient sometimes maybe together with relatives and the RN formulate a person-centred health plan This plan is part of and will be up-loaded to the eHealth platform which also contains individual notes and information about CHF and COPD The plan will be the point of departure for the forthcoming dialogue at distance via the eHealth platform that the patient and the RN will have during the study period 6 months
The eHealth support contains headings that may inspire the patient to make notes on a good day respectively a bad day The health plan contain three parts 1 My goal is to feel or be able to do 2 To be able to reach my goal I will 3Support I need to reach my goal In the communication during the study period between the RN and patient the personal health plan is discussed and any needs of reformulating the goals may be discussed The overall goal is to help the patient to identify their own capabilitiesresources such as a strong will social relations etc and formulate goals that help them increase their self-efficacy and to cope with their condition in daily life
The RN presents the eHealth support for communication computer iPad smart phone and they agree on how they will be in contact thereafter The RN invites the patient and activates their account where heshe can login via an individual user name and formulate comment evaluate or develop the health plan Access to the diary will be password protected Different forms of symptom-ratings and comments can also be made The RN can see the patients account and make comments The patient can add or delete staff or private persons that have access to the account The patient can also limit the access to the account This makes it relatively simple to connect it to the health account patient record through internet
PCC can be delivered at distance and make health care more effective above and beyond usual care Inclusion of the principles of PCC in an eHealth support for patients with chronic heart failure CHF andor chronic obstructive pulmonary disease COPD will reduce the need for medical care primary care and hospital admission amongst these patients by improving self-management self-efficacy and collaboration in the process of care
The aim of this project is to implement and evaluate the PCC approach at distance to patients with CHF andor COPD and their informal care givers to live better and cope more effectively with the disease burden associated with CHF andor COPD In the PCC approach the aims capabilities and needs of each patient will be the starting point Self-care strategies will be reinforced and empowered
This study is a randomized open parallel group intervention study where patients are eligible when they are hospitalized due to worsening CHF andor COPD They will be asked before discharge about participation
Patients admitted to hospital for worsening CHF andor COPD will be recruited by the research nurses employed in this project from Emergency or on the ward once their condition has stabilized sufficiently
Patients will be screened against inclusion and exclusion criteria for eligibility to participate in the study Written informed consent will be obtained Patients will be randomized into either the control or the intervention arm 11 The control group will receive usual care The intervention group will receive usual care plus a PCC nurse-led intervention Randomization will be done through computer generated lists and stored in sealed envelopes
Patients listed in Närhälsan with a confirmed diagnosis of CHF andor COPD will be screened and sent an informing letter about the study from the chief at each centre Specially trained registered nurses RNs will then screen patients against study inclusion and exclusion criteria and by phone contact eligible patients and inform the patient about the aims of the study and ask if they are interested to participate If the patient wants to participate a consent form is sent to the patient and then returned to the RN Then the randomization procedure is performed which is based on a computer-generated list and the patient will be informed about the outcome by phone Patients randomized to the intervention group will need a computer smart phone or iPad to participate in the study Patients who want will have the possibility to be provided an iPad for the duration of their participation in the programme
Two dedicated full-time Registered Nurses RN follow the procedures closely A monitor controls the protocol adherence All case record forms questionnaires and referrals will be constructed for intervention and usual care groups
Patients listed at a primary care centre in Närhälsan with CHF andor COPD will be randomized to usual care control or PCC intervention after informed and written consent Follow-up questionnaires on general self-efficacy cardiac self-efficacy quality of life anxiety and depression will be sent out to all patients in both groups after 3612 and 24 months after randomization
Patients randomized to usual care will be managed by regular evidence-based treatment and care as outlined in treatment guidelines and followed as usual at their local primary care centre
Patients will be called by a dedicated RN who has received special training in PCC communication at distance the eHealth platform CHF and COPD for an initial person-centred dialogue by phone Based on the patient narrative patients goals resources and needs are identified The patient sometimes maybe together with relatives and the RN formulate a person-centred health plan This plan is part of and will be up-loaded to the eHealth platform which also contains individual notes and information about CHF and COPD The plan will be the point of departure for the forthcoming dialogue at distance via the eHealth platform that the patient and the RN will have during the study period 6 months
The eHealth support contains headings that may inspire the patient to make notes on a good day respectively a bad day The health plan contain three parts 1 My goal is to feel or be able to do 2 To be able to reach my goal I will 3Support I need to reach my goal In the communication during the study period between the RN and patient the personal health plan is discussed and any needs of reformulating the goals may be discussed The overall goal is to help the patient to identify their own capabilitiesresources such as a strong will social relations etc and formulate goals that help them increase their self-efficacy and to cope with their condition in daily life
The RN presents the eHealth support for communication computer iPad smart phone and they agree on how they will be in contact thereafter The RN invites the patient and activates their account where heshe can login via an individual user name and formulate comment evaluate or develop the health plan Access to the diary will be password protected Different forms of symptom-ratings and comments can also be made The RN can see the patients account and make comments The patient can add or delete staff or private persons that have access to the account The patient can also limit the access to the account This makes it relatively simple to connect it to the health account patient record through internet
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None