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

Intermittent Claudication Clinical Trial

— FASTIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03283358
• Other study ID #: FASTIC-1
• Status: Completed
• Phase: N/A
• Start date: June 13, 2016
• Est. completion date: May 31, 2020

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Specific Aims:

1. 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

2. To investigate the effect of the intervention program on patient reported outcomes

3. To investigate the effect of the intervention program on patient reported experiences

4. 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

5. 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 Those participants who couldn't receive revascularization after giving consent will be withdrawn from the study and counted as drop outs.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: May 31, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

Behavioral:
• Person-centered follow up

Locations

Country	Name	City	State
Sweden	Department of Surgery, Unit of Vascular Surgery, Södersjukhuset	Stockholm
Sweden	Karolinska University Hospital, Dept of Vascular Surgery	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient reported adherence to medication	Patient-reported adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents).	One year after surgical or endovascular treatment for Intermittent Claudication
Other	Generic Health-related Quality of Life (HRQOL)	Patient-reported generic HrQoL measured by EQ-5D	One year after surgical or endovascular treatment for Intermittent Claudication
Other	Condition specific Health-related Quality of Life (HRQOL)	Patient-reported specific HrQoL measured by VascQol-6	One year after surgical or endovascular treatment for Intermittent Claudication
Other	Beliefs on medication	Patient-reported beliefs on medication measured by Beliefs about Meicines Questionnaire (BMQ)	One year after surgical or endovascular treatment for Intermittent Claudication
Other	Self-efficacy	Patient-reported Self-efficacy measured by Swedish Version of the General Self-Efficacy Scale	One year after surgical or endovascular treatment for Intermittent Claudication
Other	Health literacy	Patient-reported health literacy measured by HLS-EU-Q16 SE	One year after surgical or endovascular treatment for Intermittent Claudication
Other	Patient-experienced quality of care	Patient-experienced quality of care measured by Quality of Care from Patient's Perspective (Swedish version of QPP)	One year after surgical or endovascular treatment for Intermittent Claudication
Other	Mortality	Data on mortality will be extracted from the National Patient Registry and Stockholm County Council's administrative data (VårdanalysdataLager - VAL).	Ten years after surgical or endovascular treatment for Intermittent Claudication
Other	Cardiovascular disease	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).	Ten years after surgical or endovascular treatment for Intermittent Claudication
Primary	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.	One year after surgical or endovascular treatment for Intermittent Claudication
Secondary	Risk for 10-year predicted coronary heart disease (CHD)	Changes in risk for CHD within 10-years measured by Framingham Risk Score (FRHS).	One year after surgical or endovascular treatment for Intermittent Claudication