Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04706195
Status:
RECRUITING
Last Update Posted:
2023-07-05
First Post:
2021-01-04
Brief Title:
Early Accessible Person-centred Rehabilitation for Patients With Chronic Pain
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
Early Accessible Person-centred Rehabilitation With the Focus on Return to Work for Patients With Chronic Pain EAPER-P
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
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:
EAPER-P
Brief Summary:
The goal of the research project EAPER-P is to evaluate PCC person-centred care PCC in the form of a combined eHealth and telephone support for patents with chronic pain A developed PCC eHealth platform together with person-centred telephone conversations will be used as a tool to identify patients resources to enhance coping and living with their illness by means of a dialog and partnership with staff and relatives PCC in the form of a combined eHealth and telephone support will not replace but instead be used as add on treatment to usual care guideline directed care
In addition a process evaluation of the intervention will be performed in order to evaluate the mechanisms behind the intervention and evaluate which parts of the interventions the participants find useful
In addition a process evaluation of the intervention will be performed in order to evaluate the mechanisms behind the intervention and evaluate which parts of the interventions the participants find useful
Detailed Description:
Previous research and collaboration between patients relatives and professionals in the research program has clarified the need to develop a PCC accessible at home 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 project has a participatory design that 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 PCC 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
The aim of this project is to evaluate if PCC in the form of a combined eHealth and structured telephone support combined with an eHealth support available at home will improve return to work rates reduced relapse reduce costs and improved self-efficacy for patients with chronic pain
This study is a randomized open parallel group intervention study where patients on sick leave for chronic pain are eligible 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 PCC in the form of a combined eHealth and structured telephone support combined with an eHealth support Randomization will be done through computer-generated lists and stored in sealed envelopes
Patients listed in primary care with a confirmed diagnosis of chronic pain will be screened and sent an informing letter about the study from the chief at each center 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 Written informed consent will then be obtained Then the randomization procedure is performed which is stratified for age The patient will be informed about the outcome by phone Patients randomized to the intervention group will need a computer smart phone or iPad with internet access to participate in the study 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 center
In PCC the goals capabilities and needs of each patient will be the starting point Self-care strategies will be reinforced and empowered Patients in the intervention group will be contacted by a RN who has received special training in PCC communication for an initial person-centered dialogue by phone The RN presents the eHealth platform and the RN invites the patient and activates their account where heshe can login via an individual user name
During this phone conversation the participants will also be invited to tell their story Based on the patient narrative the patients goals resources and needs are identified The patient sometimes maybe together with relatives and the RN formulate a person-centered health plan This plan is part of and will be up-loaded to the eHealth platform which also contains individual notes and information about stress depression and anxiety 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 and register daily health related status 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
At the end of each phone conversation the participant and RN will agree on when and how they will be in contact next I addition to these pre-agreed on phone conversations the participants are free to contact the RNs via the eHealth platform or direct phone number
On the eHealth platform the participants can and formulate comment evaluate and develop the health plan rate and follow their symptoms and keep a diary Access to the eHealth platform will be password protected The RN can see the patients account and make comments The participants can invite other health care professionals family and friend that they want to give access to the eHealth platform The participants can add or delete these invitees when they want and they can limit the access for each invitee The RNs 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
Questionnaires on for example general self-efficacy quality of life anxiety and depression symptom burden and daily functional level will be sent to all patients in both groups at inclusion and 3 months 6 months 1 year 2 years and 5 years after randomization In addition data from registries the platform and medical records will be collected
The aim of this project is to evaluate if PCC in the form of a combined eHealth and structured telephone support combined with an eHealth support available at home will improve return to work rates reduced relapse reduce costs and improved self-efficacy for patients with chronic pain
This study is a randomized open parallel group intervention study where patients on sick leave for chronic pain are eligible 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 PCC in the form of a combined eHealth and structured telephone support combined with an eHealth support Randomization will be done through computer-generated lists and stored in sealed envelopes
Patients listed in primary care with a confirmed diagnosis of chronic pain will be screened and sent an informing letter about the study from the chief at each center 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 Written informed consent will then be obtained Then the randomization procedure is performed which is stratified for age The patient will be informed about the outcome by phone Patients randomized to the intervention group will need a computer smart phone or iPad with internet access to participate in the study 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 center
In PCC the goals capabilities and needs of each patient will be the starting point Self-care strategies will be reinforced and empowered Patients in the intervention group will be contacted by a RN who has received special training in PCC communication for an initial person-centered dialogue by phone The RN presents the eHealth platform and the RN invites the patient and activates their account where heshe can login via an individual user name
During this phone conversation the participants will also be invited to tell their story Based on the patient narrative the patients goals resources and needs are identified The patient sometimes maybe together with relatives and the RN formulate a person-centered health plan This plan is part of and will be up-loaded to the eHealth platform which also contains individual notes and information about stress depression and anxiety 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 and register daily health related status 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
At the end of each phone conversation the participant and RN will agree on when and how they will be in contact next I addition to these pre-agreed on phone conversations the participants are free to contact the RNs via the eHealth platform or direct phone number
On the eHealth platform the participants can and formulate comment evaluate and develop the health plan rate and follow their symptoms and keep a diary Access to the eHealth platform will be password protected The RN can see the patients account and make comments The participants can invite other health care professionals family and friend that they want to give access to the eHealth platform The participants can add or delete these invitees when they want and they can limit the access for each invitee The RNs 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
Questionnaires on for example general self-efficacy quality of life anxiety and depression symptom burden and daily functional level will be sent to all patients in both groups at inclusion and 3 months 6 months 1 year 2 years and 5 years after randomization In addition data from registries the platform and medical records will be collected
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