SUCCEED: A pilot study of a

heart failure self-management

program for couples

Ranak Trivedi, PhD

Investigator, Center for Innovation to Implementation

VA Palo Alto Health Care System

Assistant Professor, Dept. of Psychiatry & Behavioral Sciences

Stanford University

Background

Heart Failure (HF) is an incurable, debilitating, costly,

and life-threatening disease

Between 2010 and 2030, HF-related costs are expected to

increase from ~$25B to ~$80B

Interventions focus on improving symptom profile and

reducing exacerbations

(Benatar et al., 2003; Heidenreich et al,

2011; Heidenreich, 2013; Yu et al., 2003)

Background

Patients and informal caregivers work together

Support adherence to medical recommendations

Monitor symptoms

Provide emotional and instrumental support

Yet, self-management programs remain patient-focused

Engaging caregivers may enhance self-management

Patient barriers – complexity, depression, disability

(Piette et al., 2008; Rosalyn Carter Institute of Caregiving, 2009; Trivedi et al., 2012;

Wolff et al., 2006, Bekelman et al., 2007; Goldstein et al., 2004; Sisk et al., 2006)

Background

Caregivers experience barriers

Caregiver burden is common

Unique challenges for significant others

Tend to be older and have age-related chronic illnesses

Positively and negatively affected by caregiving role

Quality of relationship may be important

Positive relationship lead to better outcomes

Negative interactions detrimental

(Martensson et al., 2003; Pinquart and Sorenson, 2011;

Schulz and Beach, 1999; Trivedi et al., 2012)

Objective

To develop and pilot a couples’ based self-management

program for patients with HF and their spousal caregivers

(i.e., spouses or significant others) that addresses patient,

caregiver, and relationship stress

Conceptual Model

Methods

Step 1: Identify Intervention Targets

Identify intervention targets and components using

conceptual model + results of patient, caregiver, and

provider interviews

Step 2: Develop SUCCEED

a. Identify components

b. Ensure 6th grade reading level

c. Obtain feedback from Veteran and Family

Council

Step 3:

Pilot Test

SUCCEED

Obtain data related to feasibility and

acceptability

Step 1: Intervention Targets

Semi-structured interviews with 17 couples, 13 providers

Individual, family, institutional barriers to self-management

Role of relationship and family in HF self-management

Results described in next talk

Targets

Patient Skills: HF self-management, stress management

Caregiver Skills: caregiver burden, skills in managing HF

Relationship Skills: quality, communication, collaboration

Step 2: Develop Program

Adapt intervention components from 3 programs

Stanford Chronic Disease Self-management Program

Cross-disease program to enhance self-management skills

VA National Caregiver Training Program

Developed for caregivers of Veterans

Couples’ Coping Enhancement Training

CBT based program for couples managing chronic illness

Developed intervention guide, handouts, homework

Handouts obtained for the VA CHF QUERI Program

Step 2: Develop Program

Obtained feedback from the Veteran and Family Council

at the VA Palo Alto Health Care System

Revised SUCCEED to be 6 sessions (compared to 8)

Offer the option of participating over the telephone

Reviewed by VA Palo Alto Learning Center

Revised such that materials were at a 6th grade reading level

SUCCEED: Self-management Using

Couples’ Care EnhancEment in Disease

Program Characteristics

6 sessions delivered in-person or over the telephone

45-60 minutes

Delivered by Masters’ level facilitator

Sessions:

Session 1: Skills to Manage HF and Making Action Plans

Session 2 & 3: Skills to Manage Negative Emotions

Session 4 & 5: Skills to Manage Interpersonal Relationships and

Relationship Stress

Session 6: Building a Fulfilling Life & Maintaining Behavior Change

Homework: Action Plan

Step 3: Pilot Study

Eligibility criteria

Patients recruited from VA Palo Alto HCS

≥1 HF (ICD-9 code 428.XX) contact in previous year

Have a caregiver who is a cohabitating significant other

Cognitively able to participate

Not actively on hemodialysis or receiving cancer treatment

Step 3: Methods

Feasibility Measures: Recruitment and retention

Acceptability Measures: Participant feedback Feedback obtained via a 5-item Likert scale

Participants asked if the objectives of the session were reasonable, the objectives were met, the homework assigned was relevant, the participants felt that they learned something, and they believe they will use what they learned.

Rating was anonymous to minimize social desirability bias

Surveys: SF12, Minnesota Living with HF Questionnaire, Self-care for

Heart Failure Index, PHQ9, Dyadic Coping Inventory, Chronic Illness Communication Scale, Caregiver Reaction Assessment

Step 3: ResultsAssessed for eligibility

(n = 541) Excluded (n = 291)• Patient Medical (n=100)• Caregiver Medical (n=14)• Widowed (n=101)• Home based healthcare (n=23)• Other reasons (n = 38)• Eligible but letter not sent=15Sent invitation to join study

(n =250) 9/2013-1/2015

Sent consent form (n=39)

Enrolled in study (n=17)

Completed 6 sessions (n = 9)

Completed <6 sessions (n=5)

Excluded (n=211)• Patient not interested (n=92)• Unable to contact (n=41)• Patient not eligible (n=13)• Caregiver not interested (n=7)• Caregiver not eligible (n=6)• Other (n=52)

Excluded (n=22)• Unable to contact (n=9) • Patient not interested (n=8)• Caregiver not interested (n=2)• Other (n=3)

Enrollm

ent

Allo

cation

Withdrew (n=3) due to worsening health

Results: Feasibility

Iteratively refined recruitment strategies

Initially used opt-in letters, changed to opt-out letters

Edited invitation letter to clarify study description and purpose, and to better address the role of caregiver

Trained an additional facilitator

Changes improved recruitment from 3.8% to 6.8%

Higher than Bekelman et al. (2015) and Piette et al., (2016)

Changes improved rate of recruitment

Initial 7 couples: 6 months

Next 10 couples: <3 months

Patient Caregiver

Age, M (SD) 68.4 (11.3) 64.4 (11)

White Race, N (%) 11 (78.5) 11 (78.5)

Hispanic, N (%) 0 (0) 4 (28.6)

Education, N

HS or HS Diploma 3 4

Some College or Degree 10 10

Graduate School 1 0

Employment, N

Full-Time 2 3

Part-time 1 1

Retired 8 5

Not employed 3 5

Years since Diagnosis, M (SD) 5.1 (4.7)

Number of illnesses, M (SD) 8.1 (2.3) 2.7 (2.4)

Table 1: Demographics

Results: Acceptability

4

4.2

4.4

4.6

4.8

5

Reasonable Objectives Met HW Relevant Learned Applicability

1: Overview 2: Managing Negative Emotions3: Managing Negative Emotions 4: Managing Relationship Stress5: Managing Relationship Stress 6: Building a Fulfilling life

Table 2: Surveys, M (SD)

Survey Construct

Patient Caregiver

Pre Post Pre Post

Minnesota Living with HF Questionnaire HF-specific QoL 50.85(12.1) 56.14(10.6)

SF-12 General QoL

Physical Component 39.3(2.75) 33.5(1.8) 46.2(4.2) 39.43(3.4)

Mental Component 45.6(2.9) 34.3(3.9) 39.78(3) 33.3(3)

Self-care of Heart Failure Index Self-care

Maintenance 71.65(3.5) 74.2(3.3)

Management 57.8(7.3) 61.4(7.5)

Confidence 63.3(6.2) 69.5(3.8)

PHQ9 Depression 11.14(2.5) 11(2.7) 5.57(1.6) 4.7(1.9)

Dyadic Coping Inventory Relationship Quality 140.4(6.9) 142.9(6.22) 141.9(8.4) 136.3(4.9)

Chronic Illness Communication Scale Communication 14.5(1.2) 15.75(1.11) 15.63(1.3) 14.4(1.4)

Caregiver Reaction Assessment Caregiver Experience 65.1(3.36) 67(4.3)

Summary

SUCCEED has been iteratively developed based on a

strong theoretical foundation, and refined based on

feedback from content experts and key stakeholders

Results of pilot study has implications for improving self-

management among HF patients who have a

spouse/significant other

Refined the recruitment process

Understand the FTEE necessary to conduct an RCT

Encouraging results regarding acceptability and feasibility

Limitations

Small sample size due to initial recruitment challenges and funding limitations

Selection bias as this study might attract couples with low relationship conflict

Attracted patients diagnosed with HF 5+ years ago so less likely to need self-management support

Considered including only newly diagnosed HF patients, but would be underpowered in large trial

Non-HF issues were often salient but not targeted

Future Directions

Planned RCT to test the efficacy of SUCCEED

Future adaptations

Web-based adaptations

include nonspousal caregivers

target other clinical populations (e.g., PTSD)

target patients who are non-Veterans

Funding Collaborators Consultants

HSR&D CDA-09-

206

CHF QUERI LIP

Cindie Slightam, MPH

Aaron Dalton, MSW

Andrea Nevedal, PhD

John Piette, PhD

Karin Nelson, MD, MSHS

Steven M. Asch, MD, MPH

Christine Timko, PhD

Vincent S. Fan, MD, MPH

Paul L. Hebert, PhD

Steven B. Zeliadt, PhD

George Sayre, PsyD

Kate Lorig, PhD

Guy Bodenmann, PhD

Margaret Kabat, BA

Stephan D. Fihn, MD,

MPH

Daniel Kivlahan, PhD

Acknowledgments

Associations between patient and caregiver well-being n=23

couples

(Trivedi et al. 2012)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Pati

en

t

1. CES-D 1

2. IADL 1

3. Health Complaints:

Gen.50* 1

4. Health Complaints:

Spec.63** .70*† 1

5. Perceived Social

Support1

6. Dyadic Adjustment

Scale.74*† 1

7. Self Care of HF:

Conf.-.61** 1

8. Self Care of HF:

Maint.1

9. Self Care of HF:

Mgmt.1

10. Morisky 1

Sp

ou

se

11. CES-D .53* -.47* -.51* -.48* 1

12. Social Support 1

13. Dyadic Adjustment

Scale.62** -.55* 1

14. Caregiver Burden .64** .49* -.72*† -.73*† .48* 1

15. IADL .91*† -.50* 1

PT Depression*SP Depression=.53

PT Social Support*SP Burden= -.72

PT Depression*SP Burden=.64 PT Relationship

Satisfaction*SP Burden=-.73

PT Confidence*SP Depression= -.48