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The overall aim of this project is to evaluate the effects of a digital support program for patients with heart failure through a cluster-randomized controlled trial, and to investigate the outcomes of different implementation strategies using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), PRISM (Practical, Robust Implementation and Sustainability Model) and ERIC (Expert Recommendations for Implementing Change) framework.
Our primary hypothesis is that the digital support program will improve patients' perceived control over their heart failure, measured with the validated Control Attitude Scale.
Secondary hypotheses are that the program will increase patients' health-related quality of life, self-care behaviors, heart failure knowledge, perceived continuity of care, and participation in care, and reduce symptoms of depression.
Implementation aim (based on the RE-AIM, PRISM and ERIC frameworks) The implementation component of the study aims to compare two different implementation strategies: a standard (basic) support package versus a tailored, context-specific support strategy.
Heart failure clinics at hospitals an within primary care will be matched and randomized into two arms. The intervention arm will receive tailored implementation support to implement the support program. The control arm will recive implementation support according to a predefined standard procedure.
Researchers will compare the intervention arm with control arm to see if there are any differences regarding the implementationsuccess between the arms.
The patients in both arms will have access to the support program during six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored implementation | Experimental | This arm will receive tailored implementation support. |
|
| Control | No Intervention | This group will receive standard implementation of the support program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored implementation support | Other | Tailored implementation support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived control attitudes | Measured with The Control Attitudes Scale-Revised. The scale has 8 item. The possible range for the total score is from 8 to 40. Higher scores reflect greater levels of perceived control. | At enrollment and at the end of the intervention at 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Self-care | Measured using the European Heart Failure Self-care Behaviour Scale. The scale has 9 item. The possible range for the total score is from 0 to 100. Higher scores reflect greater levels of self-care. | At enrollment and at the end of the intervention at 6 month |
| Perceived control |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Stroemberg, Professor | Contact | +46736569265 | anna.stromberg@liu.se |
| Name | Affiliation | Role |
|---|---|---|
| Anna Stroemberg | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linköping University Hospital | Recruiting | Linköping | Östergötland County | 581 85 | Sweden |
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| Label | URL |
|---|---|
| Link to the support program | View source |
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Perceived Attitude Scale with 4 items. The possible range for the total score is from 4 to 28. Higher scores reflect higher levels of perceived control. |
| At enrollment and at the end of the intervention at 6 month |
| Heart failure knowledge | Heart failure knowledge scale has 3 parts. The first part has 15 knowledge questions and the possible range for the total is 0-15. Higher scores reflect greater levels of knowledge. The second part measures the trust the person with heart failure has in his/her knowledge with 3 items on a scale from 1-5 and the possible range for the total is 3-15. Higher scores reflect greater levels of trust.The third part measures perception of knowledge with 3 items on a scale from 1-5 and the possible range for the total is 3-15. Higher scores reflect greater levels of perceived knowledge. | At enrollment and at the end of the intervention at 6 month |
| Healthcare consumtion | Patient records of all health care consumption | From enrollment to 12 month follow-up |
| Health related quality of life | Measured with Euro-Qol EQ-5D, The scale has 6 item. The first 5 items comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. Item 6 is a Visual Analog Scale. The possible range for the total score is from 0 to 100. Higher scores reflect greater levels of health. | At enrollment and at the end of the intervention at 6 month |
| Disease specific health-related quality of life | Measured with Kansas City Cardiomyopathy questionnaire. The scale has 12 items assessing 4 domains (physical limitation, symptom frequency, quality of life, and social limitation), which can be reported separately into the subscales or summed into an overall score. The scales range from 0 to 100, with higher scores indicating a better health status and low symptom burden. | At enrollment and at the end of the intervention at 6 month |
| Symptoms of Depression | Measured with Patient Health Questionnare 9. The questionnaire has 9 items. The possible range for the total score is from 0 to 27. Higher score indicate more severe symptoms of depression. | At enrollment and at the end of the intervention at 6 month |
| Continuity of care | Measured with Patient experiences continuity of care with 20 items on continuity of care in 4 dimensions: information, relations, management and knowlegde. The possible range for the total score is from 20 to 80. Higher score indicate better continuity. | At enrollment and at the end of the intervention at 6 month |
| Electronic Health Literacy | Measured with Electronic health literacy scale. This scale contains 8 items and covers 3 dimensions: the ability to acquire, evaluate, and apply health information online. The scale uses a 5-point Likert scale, with responses ranging from 1 ("strongly disagree") to 5 ("strongly agree"). The total score ranges from 8 to 40, with higher scores indicating higher levels of electronic health literacy. | At enrollment and at the end of the intervention at 6 month |