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

Karolinska Institute

Status: Completed

Conditions: Intermittent Claudication

Treatments: Behavioral: Person-centered follow up

Study type: Interventional

Funder types: Other

Identifiers

NCT03283358

FASTIC-1

Details and patient eligibility

About

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.

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 Those participants who couldn't receive revascularization after giving consent will be withdrawn from the study and counted as drop outs.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

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 2 patient groups

Person-centered follow up

Experimental group

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.

Treatment:

Behavioral: Person-centered follow up

Standard follow up

No Intervention group

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.