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Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication (FASTIC)

Primary Purpose

Intermittent Claudication

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Person-centered follow up
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intermittent Claudication focused on measuring Prevention and control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients who is scheduled for revascularization, through open and/or endovascular surgery for IC diagnosed according to Diagnosis Related Group (DRG) with I70.2 or I739B

Exclusion Criteria:

  • Patients not treated through surgery or revascularization
  • Patients diagnosed with dementia
  • Patients discharge to a nursery home,
  • Patients not accountable for administrating their own medications
  • Patients with a survival expectancy less than one year

Sites / Locations

  • Department of Surgery, Unit of Vascular Surgery, Södersjukhuset
  • Karolinska University Hospital, Dept of Vascular Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Person-centered follow up

Standard follow up

Arm Description

The intervention program is a person-centered health promotion program led by a nurse and consists of two telephone calls (15 minutes each) at two weeks and nine months after surgical treatment for Intermittent Claudication and three visits (45 - 60 min) at six weeks, six months and one year after treatment. The program includes a baseline assessment, an individual plan for self-care and educational information about Intermittent Claudication, received treatment and secondary prevention (medication and modifiable risk factors). The purpose is to enhance self-care in terms of adherence to medication and to recommended changes of lifestyle.

Standard follow-up consist of two follow up appointments á 20 minutes at four-six weeks and one year after surgical treatment of Intermittent Claudication. The patients meet a vascular surgeon at the first follow up and a vascular nurse or a surgeon at the second follow up visit.

Outcomes

Primary Outcome Measures

Adherence to medication
Adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents) according to the Swedish Prescribed Drug Registry (PDR). dispensed anticoagulant agents, antiplatelet agents (ATC-register B01A) and lipid-lowering agents (ATC-register C10). Those participants who have fetched both medications for the second refill after treatment will be considered adherent.

Secondary Outcome Measures

Risk for 10-year predicted coronary heart disease (CHD)
Changes in risk for CHD within 10-years measured by Framingham Risk Score (FRHS).

Full Information

First Posted
June 13, 2016
Last Updated
October 27, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03283358
Brief Title
Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication
Acronym
FASTIC
Official Title
Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 13, 2016 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall aim of the study is to evaluate a nurse-led intervention (person-centered follow up and health promotion) program in comparison to standard follow up for patients treated with surgical or endovascular revascularization of Intermittent Claudication.
Detailed Description
Specific Aims: To evaluate the effect of the intervention program on patient's adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents), risk modification and surgical treatment outcomes To investigate the effect of the intervention program on patient reported outcomes To investigate the effect of the intervention program on patient reported experiences To investigate the long-term effect of the intervention program on mortality, cause of death, occurrence/recurrence of cardiovascular disease up to 10 years after the surgical/endovascular treatment To compare patient-reported adherence to medication and patient data registry adherence to medication Hypothesis: Participants in the Intervention Group have better adherence to prescribed medication and a reduced risk for 10-year predicted coronary heart disease (CHD) compared to participants in the Control Group. Study population: Patients with Intermittent Claudication scheduled for revascularization, through open surgery or endovascular method, in Stockholm will be screened for inclusion. After informed consent, the participants will be randomized to either Intervention Group or Control Group. Those participants who couldn't receive revascularization after giving consent will be withdrawn from the study and counted as drop outs. Power analysis has showed a required sample size of 186 participants to detect a statistically significant increase in adherence to medication from 50% to 70% (power 0.80, significance value 0.05, two-sided). Expecting 10% drop-out we plan to recruit 210 participants. Data collection: Data on primary and secondary outcomes, serum cholesterol, smoking status, serum carbon monoxide, Hba1c, BMI, waist circumference, physical exercise, diet, alcohol consumption, graft patency, re-intervention, hospitalization during the study year, mortality and patient characteristics/demographics will be collected at baseline and one year after treatment. All data will be registered at a local research data base at Karolinska Institutet. All patient-reported outcomes will be collected using web-based questionnaires linked to the data base. Data analysis: Comparisons between the Intervention Group and the Control Group will be made using t-test and ANOVA for repeated-measures or Wilcoxon rank-signed test and Kruskall-Wallis according to the underlying distribution for continuous data, and Fischers Exact test for categorical data. Logistic regression analysis will also be performed to adjust for confounding factors. All analyses will be performed according to the Intention-to-treat principle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
Prevention and control

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Person-centered follow up
Arm Type
Experimental
Arm Description
The intervention program is a person-centered health promotion program led by a nurse and consists of two telephone calls (15 minutes each) at two weeks and nine months after surgical treatment for Intermittent Claudication and three visits (45 - 60 min) at six weeks, six months and one year after treatment. The program includes a baseline assessment, an individual plan for self-care and educational information about Intermittent Claudication, received treatment and secondary prevention (medication and modifiable risk factors). The purpose is to enhance self-care in terms of adherence to medication and to recommended changes of lifestyle.
Arm Title
Standard follow up
Arm Type
No Intervention
Arm Description
Standard follow-up consist of two follow up appointments á 20 minutes at four-six weeks and one year after surgical treatment of Intermittent Claudication. The patients meet a vascular surgeon at the first follow up and a vascular nurse or a surgeon at the second follow up visit.
Intervention Type
Behavioral
Intervention Name(s)
Person-centered follow up
Primary Outcome Measure Information:
Title
Adherence to medication
Description
Adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents) according to the Swedish Prescribed Drug Registry (PDR). dispensed anticoagulant agents, antiplatelet agents (ATC-register B01A) and lipid-lowering agents (ATC-register C10). Those participants who have fetched both medications for the second refill after treatment will be considered adherent.
Time Frame
One year after surgical or endovascular treatment for Intermittent Claudication
Secondary Outcome Measure Information:
Title
Risk for 10-year predicted coronary heart disease (CHD)
Description
Changes in risk for CHD within 10-years measured by Framingham Risk Score (FRHS).
Time Frame
One year after surgical or endovascular treatment for Intermittent Claudication
Other Pre-specified Outcome Measures:
Title
Patient reported adherence to medication
Description
Patient-reported adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents).
Time Frame
One year after surgical or endovascular treatment for Intermittent Claudication
Title
Generic Health-related Quality of Life (HRQOL)
Description
Patient-reported generic HrQoL measured by EQ-5D
Time Frame
One year after surgical or endovascular treatment for Intermittent Claudication
Title
Condition specific Health-related Quality of Life (HRQOL)
Description
Patient-reported specific HrQoL measured by VascQol-6
Time Frame
One year after surgical or endovascular treatment for Intermittent Claudication
Title
Beliefs on medication
Description
Patient-reported beliefs on medication measured by Beliefs about Meicines Questionnaire (BMQ)
Time Frame
One year after surgical or endovascular treatment for Intermittent Claudication
Title
Self-efficacy
Description
Patient-reported Self-efficacy measured by Swedish Version of the General Self-Efficacy Scale
Time Frame
One year after surgical or endovascular treatment for Intermittent Claudication
Title
Health literacy
Description
Patient-reported health literacy measured by HLS-EU-Q16 SE
Time Frame
One year after surgical or endovascular treatment for Intermittent Claudication
Title
Patient-experienced quality of care
Description
Patient-experienced quality of care measured by Quality of Care from Patient's Perspective (Swedish version of QPP)
Time Frame
One year after surgical or endovascular treatment for Intermittent Claudication
Title
Mortality
Description
Data on mortality will be extracted from the National Patient Registry and Stockholm County Council's administrative data (VårdanalysdataLager - VAL).
Time Frame
Ten years after surgical or endovascular treatment for Intermittent Claudication
Title
Cardiovascular disease
Description
Data on occurrence/reoccurrence of cardiovascular disease with hospitalization will be extracted from the National Patient Registry and Stockholm County Council's administrative data (VårdanalysdataLager - VAL).
Time Frame
Ten years after surgical or endovascular treatment for Intermittent Claudication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients who is scheduled for revascularization, through open and/or endovascular surgery for IC diagnosed according to Diagnosis Related Group (DRG) with I70.2 or I739B Exclusion Criteria: Patients not treated through surgery or revascularization Patients diagnosed with dementia Patients discharge to a nursery home, Patients not accountable for administrating their own medications Patients with a survival expectancy less than one year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anneli Linné, MD, PhD
Organizational Affiliation
Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Unit of Vascular Surgery, Södersjukhuset
City
Stockholm
ZIP/Postal Code
SE-11883
Country
Sweden
Facility Name
Karolinska University Hospital, Dept of Vascular Surgery
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32518518
Citation
Haile S, Linne A, Johansson UB, Joelsson-Alm E. Follow-up after surgical treatment for intermittent claudication (FASTIC): a study protocol for a multicentre randomised controlled clinical trial. BMC Nurs. 2020 Jun 4;19:45. doi: 10.1186/s12912-020-00437-7. eCollection 2020.
Results Reference
derived

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Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication

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