N/A N=45 Randomized Single-blind Treatment

Researching Emotions And Cardiac Health: Phase III

Congestive Heart Failure · Emotions · Patient Compliance

Bottom Line

View on ClinicalTrials.gov: NCT03220204 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Apr 2020

Primary outcome: Primary: Feasibility of the PP-based Health Behavior Intervention — 8.7 sessions completed out of 12 sessions

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PP-based health behavior intervention (Behavioral); MI-based educational control condition (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of the PP-based Health Behavior Intervention	8.7	—
SECONDARY Acceptability of the Exercises	7.5; 7.5	—
SECONDARY Immediate Impact of the Exercises	0.64; 0.97	—
SECONDARY Change in PANAS Scores (Primary Psychological Outcome)	5.38; 2.50; 2.50; 5.43; -0.46; 3.75	—
SECONDARY Changes in LOT-R Scores	2.43; 1.29; 2.93; 3.50; 1.23; 2.83	—
SECONDARY Changes in SOM Scores	2.14; 1.29; 2.36; 2.00; 1.38; -0.17	—
SECONDARY Changes in HADS-Anxiety Subscale Scores	-1.79; -2.00; -2.07; -2.21; -1.69; -2.50	—
SECONDARY Change in HADS-Depression Subscale Scores	-1.57; -0.93; -1.00; -1.57; -0.38; -1.00	—
SECONDARY Changes in KCCQ Scores (Primary Functional Outcome)	7.74; 4.76; 10.12; 2.31; -1.19; 2.60	—
SECONDARY Changes in SF-12 Scores	7.03; 1.51; 5.19; 1.88; 0.42; 0.83	—
SECONDARY Changes in MOS SAS Scores	2.50; 2.64; 1.14; 2.29; 2.23; 1.42	—
SECONDARY Changes in Sodium Intake (as Measured With the SSQ)	-18.25; -12.93; -11.68; -13.18; -14.65; -0.63	—
SECONDARY Changes in Self-Reported Medication Adherence (SRMA)	43; 0; 21; 36; 8; 8	—
SECONDARY Change in Physical Activity	454; 409; -412; 821; -330; 76	—
SECONDARY Change in Moderate to Vigorous Physical Activity	5.72; 0.27; -4.11; 5.18; -2.66; -1.32	—
SECONDARY Feasibility of Actigraph	11; 13; 11; 12; 11; 10	—

Summary

The focus of this study is to examine the feasibility, acceptability, and preliminary impact of a 12-week, telephone-delivered, positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF), compared to a motivational interviewing- (MI-) based education condition and treatment as usual (TAU).

Eligibility Criteria

Inclusion Criteria

Adult patients with NYHA class I, II, or III HF admitted to an MGH inpatient unit or outpatients at the MGH Heart Center or MGH-affiliated primary care clinic. Patients with NYHA class IV HF have ongoing HF symptoms at rest, making it difficult for them to increase physical activity and other health behaviors; therefore, they will not be included. HF diagnosis will be confirmed via chart review and with the patient's treatment team as needed.
Suboptimal adherence to health behaviors. This will be defined as a total score of ≤15 on three Medical Outcomes Study Specific Adherence Scale (MOS) items regarding diet/exercise/medications. The MOS has been used in multiple prior studies assessing adherence in cardiac patients, including our own studies in this population. This threshold score on the MOS will ensure that all participants will have the potential to improve their health behaviors.

Exclusion Criteria

Cognitive deficits impeding a participant's ability to provide informed consent or participate, assessed via a 6-item cognitive test that is sensitive and specific for screening for cognitive impairment in research participants.
Medical conditions precluding interviews or likely to lead to death within 6 months.
Inability to speak English, inability to read or write, inability to walk, or lack of a telephone.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03220204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.