N/A
N=10
Researching Emotions And Cardiac Health (REACH): Phase II
Congestive Heart Failure · Emotions · Patient Compliance
Bottom Line
View on ClinicalTrials.gov: NCT02938052 ↗Enrolled (actual)
10
Serious AEs
20.0%
Results posted
Sep 2018
Primary outcome: Primary: Feasibility of the PP-based Health Behavior Intervention — 7.8 Exercises Completed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PP-based health behavior intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the PP-based Health Behavior Intervention |
7.8 | — |
| SECONDARY Changes in PANAS Scores |
2.44 | — |
| SECONDARY Changes in LOT-R Scores |
1.56 | — |
| SECONDARY Changes in HADS-Anxiety Subscale Scores |
2.0 | — |
| SECONDARY Change in HADS-Depression Subscale Scores |
.11 | — |
| SECONDARY Changes in KCCQ Scores |
5.56; 6.60 | — |
| SECONDARY Changes in SF-12 Scores |
2.44; 2.17 | — |
| SECONDARY Changes in MOS SAS Scores |
2.78 | — |
| SECONDARY Changes in Daily Sodium Intake (as Measured With the SSQ) |
16.31 | — |
| SECONDARY Self-Reported Medication Adherence (SRMA) |
.44 | — |
| SECONDARY Change in Physical Activity |
706 | — |
| SECONDARY Change in Moderate to Vigorous Physical Activity (Actigraph) |
.15 | — |
| SECONDARY Feasibility of Actigraph |
9; 8 | — |
| SECONDARY Acceptability of the Exercises: Utility Score |
7.8 | — |
| SECONDARY Acceptability of the Exercises: Ease Score |
7.5 | — |
| SECONDARY Immediate Impact of the Exercises: Optimism Rating |
8.2; 8.4 | — |
| SECONDARY Immediate Impact of the Exercises: Positive Affect Rating |
7.8; 8.6 | — |
Summary
The focus of this study is to examine the feasibility, acceptability, and preliminary impact of our customized positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF).
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. 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 SAS) items regarding diet/exercise/medications. The MOS SAS 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 SAS 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.
Data sourced from ClinicalTrials.gov (NCT02938052). 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.