Trial Outcomes & Findings for Post-chemotherapy Symptom Management SMART (NCT NCT03494166)

Last Updated: 2023-10-19

Results Overview

Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 symptoms: fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicated the severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index for 17 symptoms other than depression was averaged over weeks 1-13 from each weekly contact, baseline, and 13-week interviews. Potential range 0-170, with higher score indicating worse outcome (greater severity). Because the collection of symptoms does not form a scale, internal consistency reliability was not applicable.

Recruitment status

COMPLETED

Study phase

Target enrollment

498 participants

Primary outcome timeframe

Weeks 1-13

Results posted on

2023-10-19

Participant Flow

Cancer survivors were recruited at a comprehensive cancer center, a federally qualified health center, and community settings in the Southwestern United States. Participants were informed they would be 1) randomized to SMSH or TIPC+SMSH and may be rerandomized after 4 weeks to continue with SMSH alone or add TIPC; 2) telephone assessment and intervention sessions were weekly for 13 weeks; 3) interventions were designed to help reduce symptoms and there were study incentives.

Of 500 consented individuals, 451 had a baseline interview, 71 were low need, 375 were high need and entered into randomization. Five participants were found ineligible. Three participants in the high need group dropped out after baseline before the first randomization. Three participants in the low need group were misclassified initially as high need and were randomized, resulting in 375 randomized and 68 continuing as low need without interventions.

Participant milestones

Participant milestones
Measure	Low Need Benchmark or Follow-up In the low need benchmark or follow-up group, participants received baseline and 13-week assessments (about 30-40 minutes) over the telephone. A brief assessment (about 5 minutes) was done at week 4 over the telephone to assess symptoms. Approximately 35% of all participants were in this group.	High Need- SMSH Alone for 4 Weeks, Depression Responders Continued With SMSH Alone for Weeks 5-12 Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression responders in the High Need group continued with the SMSH alone for weeks 5-12. Depression responders were survivors who started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the participant was called to complete the second assessment.	High Need-SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH Alone for Weeks 5-12 Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression non-responders were re-randomized to either continue with the SMSH alone for weeks 5-12 or add Telephone Interpersonal Counseling (TIPC) to test the value added by the more intensive intervention. Symptom cases that remained moderate or became severe at week 4 are classified as non-responders. At week 13, the participant was called to complete the second assessment.	High Need- SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH+TIPC for Weeks 5-12 Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression non-responders were re-randomized to either continue with the SMSH alone for weeks 5-12 or add Telephone Interpersonal Counseling (TIPC) to test the value added by the more intensive intervention. The TIPC counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship. Symptom cases that remained moderate or became severe at week 4 are classified as non-responders. At week 13, the participant was called to complete the second assessment.	High Need- SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12 Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for the first 8 weeks using a combination of Telephone Interpersonal Counseling (TIPC) and SMSH. The TIPC counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship as well as asked about symptoms and suggest strategies from the SMSH to relieve symptoms. At weeks 9-12, the participant received the SMSH alone. At week 13, the participant was called to complete the second assessment.	Drop-outs From SMSH Alone Prior to Week 4 Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. These participants were lost to attrition prior to the week 4 assessment for response or non-response.
Overall Study STARTED	71	204	30	31	93	17
Overall Study COMPLETED	58	195	28	23	72	0
Overall Study NOT COMPLETED	13	9	2	8	21	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Low Need Benchmark or Follow-up In the low need benchmark or follow-up group, participants received baseline and 13-week assessments (about 30-40 minutes) over the telephone. A brief assessment (about 5 minutes) was done at week 4 over the telephone to assess symptoms. Approximately 35% of all participants were in this group.	High Need- SMSH Alone for 4 Weeks, Depression Responders Continued With SMSH Alone for Weeks 5-12 Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression responders in the High Need group continued with the SMSH alone for weeks 5-12. Depression responders were survivors who started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the participant was called to complete the second assessment.	High Need-SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH Alone for Weeks 5-12 Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression non-responders were re-randomized to either continue with the SMSH alone for weeks 5-12 or add Telephone Interpersonal Counseling (TIPC) to test the value added by the more intensive intervention. Symptom cases that remained moderate or became severe at week 4 are classified as non-responders. At week 13, the participant was called to complete the second assessment.	High Need- SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH+TIPC for Weeks 5-12 Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression non-responders were re-randomized to either continue with the SMSH alone for weeks 5-12 or add Telephone Interpersonal Counseling (TIPC) to test the value added by the more intensive intervention. The TIPC counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship. Symptom cases that remained moderate or became severe at week 4 are classified as non-responders. At week 13, the participant was called to complete the second assessment.	High Need- SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12 Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for the first 8 weeks using a combination of Telephone Interpersonal Counseling (TIPC) and SMSH. The TIPC counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship as well as asked about symptoms and suggest strategies from the SMSH to relieve symptoms. At weeks 9-12, the participant received the SMSH alone. At week 13, the participant was called to complete the second assessment.	Drop-outs From SMSH Alone Prior to Week 4 Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. These participants were lost to attrition prior to the week 4 assessment for response or non-response.
Overall Study Death	0	0	0	1	3	0
Overall Study Lost to Follow-up	2	2	2	2	14	0
Overall Study Withdrawal by Subject	10	7	0	5	3	17
Overall Study Screen failure	1	0	0	0	1	0

Baseline Characteristics

Post-chemotherapy Symptom Management SMART

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Need Benchmark or Follow-up n=71 Participants In the low need benchmark or follow-up group, participants received baseline and 13-week assessments (about 30-40 minutes) over the telephone. A brief assessment (about 5 minutes) was done at week 4 over the telephone to assess symptoms. Approximately 35% of all participants were in this group.	High Need-SMSH Alone for 4 Weeks, Depression Responders Continued With SMSH Alone for Weeks 5-12 n=204 Participants Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression responders in the High Need group continued with the SMSH alone for weeks 5-12. Depression responders are survivors who started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the participant was called to complete the second assessment.	High Need-SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH Alone for Weeks 5-12 n=30 Participants Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression non-responders were re-randomized to either continue with the SMSH alone for weeks 5-12 or add Telephone Interpersonal Counseling (TIPC) to test the value added by the more intensive intervention. Symptom cases that remained moderate or became severe at week 4 are classified as non-responders. At week 13, the participant was called to complete the second assessment.	High Need- SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH+TIPC for Weeks 5-12 n=31 Participants Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, depression non-responders were re-randomized to either continue with the SMSH alone for weeks 5-12 or add Telephone Interpersonal Counseling (TIPC) to test the value added by the more intensive intervention. The TIPC counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship. Symptom cases that remained moderate or became severe at week 4 are classified as non-responders. At week 13, the participant was called to complete the second assessment.	High Need- SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12 n=93 Participants Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for the first 8 weeks using a combination of Telephone Interpersonal Counseling (TIPC) and SMSH. The TIPC counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship as well as asked about symptoms and suggest strategies from the SMSH to relieve symptoms. At weeks 9-12, the participant received the SMSH alone. At week 13, the participant was called to complete the second assessment.	Drop-outs From SMSH Alone Prior to Week 4 n=17 Participants Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The High Need group participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. These participants were lost to attrition prior to the week 4 assessment for response or non-response.	Total n=446 Participants Total of all reporting groups
Age, Continuous	53.56 years STANDARD_DEVIATION 13.13 • n=5 Participants	58.76 years STANDARD_DEVIATION 12.31 • n=7 Participants	60.63 years STANDARD_DEVIATION 12.88 • n=5 Participants	53.83 years STANDARD_DEVIATION 15.31 • n=4 Participants	58.26 years STANDARD_DEVIATION 12.93 • n=21 Participants	60.18 years STANDARD_DEVIATION 9.04 • n=8 Participants	57.67 years STANDARD_DEVIATION 12.73 • n=8 Participants
Sex/Gender, Customized Male	22 Participants n=5 Participants	32 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	14 Participants n=21 Participants	2 Participants n=8 Participants	80 Participants n=8 Participants
Sex/Gender, Customized Female	49 Participants n=5 Participants	172 Participants n=7 Participants	25 Participants n=5 Participants	25 Participants n=4 Participants	78 Participants n=21 Participants	15 Participants n=8 Participants	364 Participants n=8 Participants
Sex/Gender, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Sex/Gender, Customized Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	8 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Race/Ethnicity, Customized White	36 Participants n=5 Participants	121 Participants n=7 Participants	19 Participants n=5 Participants	14 Participants n=4 Participants	56 Participants n=21 Participants	11 Participants n=8 Participants	257 Participants n=8 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Race/Ethnicity, Customized Unknown or not reported	30 Participants n=5 Participants	83 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	28 Participants n=21 Participants	4 Participants n=8 Participants	167 Participants n=8 Participants
Race/Ethnicity, Customized Hispanic or Latino	39 Participants n=5 Participants	92 Participants n=7 Participants	13 Participants n=5 Participants	13 Participants n=4 Participants	45 Participants n=21 Participants	8 Participants n=8 Participants	210 Participants n=8 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	32 Participants n=5 Participants	111 Participants n=7 Participants	17 Participants n=5 Participants	18 Participants n=4 Participants	48 Participants n=21 Participants	9 Participants n=8 Participants	235 Participants n=8 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Symptom Severity	24.70 units on a scale STANDARD_DEVIATION 20.35 • n=5 Participants	36.32 units on a scale STANDARD_DEVIATION 25.48 • n=7 Participants	46.97 units on a scale STANDARD_DEVIATION 22.81 • n=5 Participants	48.13 units on a scale STANDARD_DEVIATION 26.46 • n=4 Participants	37.28 units on a scale STANDARD_DEVIATION 24.65 • n=21 Participants	56.06 units on a scale STANDARD_DEVIATION 34.18 • n=8 Participants	36.96 units on a scale STANDARD_DEVIATION 24.85 • n=8 Participants
Depressive Symptoms	6.01 units on a scale STANDARD_DEVIATION 4.66 • n=5 Participants	13.01 units on a scale STANDARD_DEVIATION 11.08 • n=7 Participants	23.35 units on a scale STANDARD_DEVIATION 12.69 • n=5 Participants	23.72 units on a scale STANDARD_DEVIATION 2.72 • n=4 Participants	16.36 units on a scale STANDARD_DEVIATION 13.42 • n=21 Participants	19.25 units on a scale STANDARD_DEVIATION 13.72 • n=8 Participants	14.28 units on a scale STANDARD_DEVIATION 11.92 • n=8 Participants

PRIMARY outcome

Timeframe: Weeks 1-13

Population: Of the 375 high-need survivors initially randomized, 282 received the Symptom Management and Survivorship Handbook (SMSH) alone and 93 received Telephone Interpersonal Counseling (TIPC) + SMSH.

Outcome measures

Outcome measures
Measure	High Need A; Start With SMSH Alone n=282 Participants Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The Group A participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, participants were re-randomized to continue in SMSH for 8 more weeks or to add Telephone Interpersonal Counseling (TIP-C) Intervention for the subsequent 8 weeks. If the TIP-C was added, the counselor called the participant once per week for about 35-40 minutes to assess and discuss strategies for managing symptoms, provide survivorship education, and discuss interpersonal relationships, communication, and social support. At week 13, the participant was called to complete the second assessment. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions	High Need B: Start With SMSH+TIPC n=93 Participants Participant was called every week for the first 8 weeks using a combination of TIP-C and SMSH. The counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship. At the end of 8 weeks, the final 4 calls were focused on the SMSH protocol. At week 13, the second assessment was conducted. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions
Symptom Severity Index- Comparison of Two Groups Created by First Randomization	24.53 score on a scale Standard Error 0.68	25.86 score on a scale Standard Error 1.15

PRIMARY outcome

Timeframe: Weeks 5-13

Population: Non-responders to the SMSH alone after 4 weeks.

Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 symptoms: fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicated severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index for 17 symptoms other than depression was averaged over weeks 5-13 from each weekly contact, baseline, and 13-week interviews. Potential range 0-170, higher value reflect worse outcome (greater symptom severity). Because the collection of symptoms does not form a scale, internal consistency reliability was not applicable.

Outcome measures

Outcome measures
Measure	High Need A; Start With SMSH Alone n=30 Participants Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The Group A participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, participants were re-randomized to continue in SMSH for 8 more weeks or to add Telephone Interpersonal Counseling (TIP-C) Intervention for the subsequent 8 weeks. If the TIP-C was added, the counselor called the participant once per week for about 35-40 minutes to assess and discuss strategies for managing symptoms, provide survivorship education, and discuss interpersonal relationships, communication, and social support. At week 13, the participant was called to complete the second assessment. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions	High Need B: Start With SMSH+TIPC n=31 Participants Participant was called every week for the first 8 weeks using a combination of TIP-C and SMSH. The counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship. At the end of 8 weeks, the final 4 calls were focused on the SMSH protocol. At week 13, the second assessment was conducted. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions
Symptom Severity Index- Comparison of Two Groups Created by Second Randomization	35.94 score on a scale Standard Error 2.38	38.11 score on a scale Standard Error 2.49

SECONDARY outcome

Timeframe: Week 13

Population: Of the 375 high-need survivors initially randomized, 282 started with the Symptom Management and Survivorship Handbook (SMSH) alone and 93 received Telephone Interpersonal Counseling (TIPC) + SMSH.

Measured using Center for Epidemiological Studies-Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms).

Outcome measures

Outcome measures
Measure	High Need A; Start With SMSH Alone n=282 Participants Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The Group A participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, participants were re-randomized to continue in SMSH for 8 more weeks or to add Telephone Interpersonal Counseling (TIP-C) Intervention for the subsequent 8 weeks. If the TIP-C was added, the counselor called the participant once per week for about 35-40 minutes to assess and discuss strategies for managing symptoms, provide survivorship education, and discuss interpersonal relationships, communication, and social support. At week 13, the participant was called to complete the second assessment. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions	High Need B: Start With SMSH+TIPC n=93 Participants Participant was called every week for the first 8 weeks using a combination of TIP-C and SMSH. The counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship. At the end of 8 weeks, the final 4 calls were focused on the SMSH protocol. At week 13, the second assessment was conducted. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions
Depressive Symptoms- Comparison of Two Groups Created by First Randomization.	11.89 score on a scale Standard Error .55	12.30 score on a scale Standard Error .99

SECONDARY outcome

Timeframe: Week 13

Population: Non-responders to the SMSH alone after 4 weeks randomized for the second time (N=61).

Measured using Center for Epidemiological Studies-Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms).

Outcome measures

Outcome measures
Measure	High Need A; Start With SMSH Alone n=30 Participants Participants were mailed the printed Symptom Management and Survivorship Handbook (SMSH). The Group A participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMSH to relieve symptoms. Calls were approximately 10 minutes. After 4 weeks, participants were re-randomized to continue in SMSH for 8 more weeks or to add Telephone Interpersonal Counseling (TIP-C) Intervention for the subsequent 8 weeks. If the TIP-C was added, the counselor called the participant once per week for about 35-40 minutes to assess and discuss strategies for managing symptoms, provide survivorship education, and discuss interpersonal relationships, communication, and social support. At week 13, the participant was called to complete the second assessment. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions	High Need B: Start With SMSH+TIPC n=31 Participants Participant was called every week for the first 8 weeks using a combination of TIP-C and SMSH. The counselor assessed and discussed interpersonal relationships, communication, social support, managing symptoms, and survivorship. At the end of 8 weeks, the final 4 calls were focused on the SMSH protocol. At week 13, the second assessment was conducted. Telephone Interpersonal Counseling (TIP-C): See arm/group descriptions
Depressive Symptoms - Comparison of Two Groups Created by Second Randomization	16.05 score on a scale Standard Error 1.93	16.81 score on a scale Standard Error 2.11

Adverse Events

Low Need Benchmark or Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Need A-SMH or TIP-C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

High Need B-TIP-C+SMH

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Terry Badger, PhD (MPI) and Alla Sikorskii, PhD (MPI)

University of Arizona College of Nursing

Phone: 520-626-6058

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place